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Meta-Analysis
. 2020 Dec 8;12(12):CD012875.
doi: 10.1002/14651858.CD012875.pub2.

Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age

Samantha L Huey  1 , Nina Acharya  1 , Ashley Silver  1 , Risha Sheni  1 , Elaine A Yu  1 , Juan Pablo Peña-Rosas  2 , Saurabh Mehta  1
Affiliations
Meta-Analysis

Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age

Samantha L Huey et al. Cochrane Database Syst Rev. .

Abstract

Background: Vitamin D is a secosteroid hormone that is important for its role in calcium homeostasis to maintain skeletal health. Linear growth faltering and stunting remain pervasive indicators of poor nutrition status among infants and children under five years of age around the world, and low vitamin D status has been linked to poor growth. However, existing evidence on the effects of vitamin D supplementation on linear growth and other health outcomes among infants and children under five years of age has not been systematically reviewed.

Objectives: To assess effects of oral vitamin D supplementation on linear growth and other health outcomes among infants and children under five years of age.

Search methods: In December 2019, we searched CENTRAL, PubMed, Embase, 14 other electronic databases, and two trials registries. We also searched the reference lists of relevant publications for any relevant trials, and we contacted key organisations and authors to obtain information on relevant ongoing and unpublished trials.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs assessing the effects of oral vitamin D supplementation, with or without other micronutrients, compared to no intervention, placebo, a lower dose of vitamin D, or the same micronutrients alone (and not vitamin D) in infants and children under five years of age who lived in any country.

Data collection and analysis: We used standard Cochrane methodological procedures.

Main results: Out of 75 studies (187 reports; 12,122 participants) included in the qualitative analysis, 64 studies (169 reports; 10,854 participants) contributed data on our outcomes of interest for meta-analysis. A majority of included studies were conducted in India, USA, and Canada. Two studies reported for-profit funding, two were categorised as receiving mixed funding (non-profit and for-profit), five reported that they received no funding, 26 did not disclose funding sources, and the remaining studies were funded by non-profit funding. Certainty of evidence varied between high and very low across outcomes (all measured at endpoint) for each comparison. Vitamin D supplementation versus placebo or no intervention (31 studies) Compared to placebo or no intervention, vitamin D supplementation (at doses 200 to 2000 IU daily; or up to 300,000 IU bolus at enrolment) may make little to no difference in linear growth (measured length/height in cm) among children under five years of age (mean difference (MD) 0.66, 95% confidence interval (CI) -0.37 to 1.68; 3 studies, 240 participants; low-certainty evidence); probably improves length/height-for-age z-score (L/HAZ) (MD 0.11, 95% CI 0.001 to 0.22; 1 study, 1258 participants; moderate-certainty evidence); and probably makes little to no difference in stunting (risk ratio (RR) 0.90, 95% CI 0.80 to 1.01; 1 study, 1247 participants; moderate-certainty evidence). In terms of adverse events, vitamin D supplementation results in little to no difference in developing hypercalciuria compared to placebo (RR 2.03, 95% CI 0.28 to 14.67; 2 studies, 68 participants; high-certainty evidence). It is uncertain whether vitamin D supplementation impacts the development of hypercalcaemia as the certainty of evidence was very low (RR 0.82, 95% CI 0.35 to 1.90; 2 studies, 367 participants). Vitamin D supplementation (higher dose) versus vitamin D (lower dose) (34 studies) Compared to a lower dose of vitamin D (100 to 1000 IU daily; or up to 300,000 IU bolus at enrolment), higher-dose vitamin D supplementation (200 to 6000 IU daily; or up to 600,000 IU bolus at enrolment) may have little to no effect on linear growth, but we are uncertain about this result (MD 1.00, 95% CI -2.22 to 0.21; 5 studies, 283 participants), and it may make little to no difference in L/HAZ (MD 0.40, 95% CI -0.06 to 0.86; 2 studies, 105 participants; low-certainty evidence). No studies evaluated stunting. As regards adverse events, higher-dose vitamin D supplementation may make little to no difference in developing hypercalciuria (RR 1.16, 95% CI 1.00 to 1.35; 6 studies, 554 participants; low-certainty evidence) or in hypercalcaemia (RR 1.39, 95% CI 0.89 to 2.18; 5 studies, 986 participants; low-certainty evidence) compared to lower-dose vitamin D supplementation. Vitamin D supplementation (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s) (9 studies) Supplementation with a higher dose of vitamin D (400 to 2000 IU daily, or up to 300,000 IU bolus at enrolment) plus micronutrients, compared to a lower dose (200 to 2000 IU daily, or up to 90,000 IU bolus at enrolment) of vitamin D with the same micronutrients, probably makes little to no difference in linear growth (MD 0.60, 95% CI -3.33 to 4.53; 1 study, 25 participants; moderate-certainty evidence). No studies evaluated L/HAZ or stunting. In terms of adverse events, higher-dose vitamin D supplementation with micronutrients, compared to lower-dose vitamin D with the same micronutrients, may make little to no difference in developing hypercalciuria (RR 1.00, 95% CI 0.06 to 15.48; 1 study, 86 participants; low-certainty evidence) and probably makes little to no difference in developing hypercalcaemia (RR 1.00, 95% CI 0.90, 1.11; 2 studies, 126 participants; moderate-certainty evidence). Four studies measured hyperphosphataemia and three studies measured kidney stones, but they reported no occurrences and therefore were not included in the comparison for these outcomes.

Authors' conclusions: Evidence suggests that oral vitamin D supplementation may result in little to no difference in linear growth, stunting, hypercalciuria, or hypercalcaemia, compared to placebo or no intervention, but may result in a slight increase in length/height-for-age z-score (L/HAZ). Additionally, evidence suggests that compared to lower doses of vitamin D, with or without micronutrients, vitamin D supplementation may result in little to no difference in linear growth, L/HAZ, stunting, hypercalciuria, or hypercalcaemia. Small sample sizes, substantial heterogeneity in terms of population and intervention parameters, and high risk of bias across many of the included studies limit our ability to confirm with any certainty the effects of vitamin D on our outcomes. Larger, well-designed studies of long duration (several months to years) are recommended to confirm whether or not oral vitamin D supplementation may impact linear growth in children under five years of age, among both those who are healthy and those with underlying infectious or non-communicable health conditions.

Trial registration: ClinicalTrials.gov NCT02273843 NCT01419262 NCT03793309 NCT01469650 NCT02941185 NCT02197702 NCT01600430 NCT01190137 NCT00381914 NCT01042561 NCT01601847 NCT01723852 NCT01999907 NCT00548379 NCT01288950 NCT00846677 NCT03170479 NCT03799406 NCT00949832 NCT00415402 NCT00868738 NCT01532349 NCT00879424 NCT00536276 NCT02058186 NCT01229189 NCT03176849 NCT01838447 NCT02404623.

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Conflict of interest statement

Samantha L Huey: none known.

Nina Acharya: none known.

Ashley Silver: none known.

Risha Sheni: none known.

Elaine Yu: none known.

Juan Pablo Peña‐Rosas: the WHO receives partial financial support from the Bill & Melinda Gates Foundation to support commissioning of systematic reviews of interventions for health throughout the life course. Donors do not fund specific guidelines and do not participate in any decision related to the guideline development process, including the composition of policy questions, membership of the guideline groups, the conduct and interpretation of systematic reviews, or the formulation of recommendations.

Disclaimer: Juan Peña‐Rosas is a full‐time staff member at the World Health Organization. The review authors alone are responsible for the views expressed in this publication, which do not necessarily represent the official position, decisions, policy, or views of the WHO.

Saurabh Mehta (SM) is an unpaid board member with an equity stake/stocks/stock options in a diagnostic start‐up company, VitaScan, which is focused on developing assays for low‐cost and point‐of‐care measurement of certain nutrients from a drop of blood, using results from his research as a faculty member at Cornell University. SM is also the principal investigator on competitive research grants from HarvestPlus/International Food Policy Research Institute to conduct efficacy trials for crops biofortified with iron, zinc, and vitamin A among children in India, for which the outcomes include child growth and nutritional status. SM was paid a consulting fee as external reviewer for the nutrition programme at New York Academy of Sciences and was paid travel and accommodation expenses by Foundation Merieux for a conference presentation on precision nutrition and gut microbiome. SM received partial financial support for this work from the WHO.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 1: Linear growth
1.2
1.2. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 2: Length/height‐for‐age
1.3
1.3. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 3: Stunting
1.4
1.4. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 4: Adverse effect: hypercalciuria
1.5
1.5. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 5: Adverse effect: hypercalcaemia
1.6
1.6. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 6: Weight‐for‐age
1.7
1.7. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 7: Underweight
1.8
1.8. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 8: Weight‐for‐length/height
1.9
1.9. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 9: Wasting
1.10
1.10. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 10: Serum 25‐hydroxyvitamin D
1.11
1.11. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 11: Change in 25(OH)D levels (nmol/L)
1.12
1.12. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 12: Vitamin D sufficiency (≥ 50 nmol/L)
1.13
1.13. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 13: Vitamin D sufficiency (≥ 75 nmol/L)
1.14
1.14. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 14: Vitamin D severe deficiency (< 25 to 30 nmol/L)
1.15
1.15. Analysis
Comparison 1: Vitamin D versus placebo or no intervention, Outcome 15: Rickets (continuous)
2.1
2.1. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 1: Linear growth
2.2
2.2. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 2: Length/height‐for‐age
2.3
2.3. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 3: Adverse effect: hypercalciuria
2.4
2.4. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 4: Adverse effect: hypercalcaemia
2.5
2.5. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 5: Linear growth: gain in length
2.6
2.6. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 6: Weight‐for‐age
2.7
2.7. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 7: Weight‐for‐length/height
2.8
2.8. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 8: Serum 25‐hydroxyvitamin D
2.9
2.9. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 9: Change in 25(OH)D (nmol/L)
2.10
2.10. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 10: Vitamin D sufficiency (≥ 50 nmol/L)
2.11
2.11. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 11: Vitamin D sufficiency (≥ 75 nmol/L)
2.12
2.12. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 12: Vitamin D severe deficiency (< 25 to 30 nmol/L)
2.13
2.13. Analysis
Comparison 2: Vitamin D (higher dose) versus vitamin D (lower dose), Outcome 13: Rickets (dichotomous)
3.1
3.1. Analysis
Comparison 3: Vitamin D + micronutrient(s) versus micronutrient(s) alone, Outcome 1: Serum 25‐hydroxyvitamin D
3.2
3.2. Analysis
Comparison 3: Vitamin D + micronutrient(s) versus micronutrient(s) alone, Outcome 2: Rickets (continuous)
4.1
4.1. Analysis
Comparison 4: Vitamin D (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s), Outcome 1: Linear growth
4.2
4.2. Analysis
Comparison 4: Vitamin D (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s), Outcome 2: Adverse effect: hypercalciuria
4.3
4.3. Analysis
Comparison 4: Vitamin D (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s), Outcome 3: Adverse effect: hypercalcaemia
4.4
4.4. Analysis
Comparison 4: Vitamin D (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s), Outcome 4: Linear growth: gain in length
4.5
4.5. Analysis
Comparison 4: Vitamin D (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s), Outcome 5: Serum 25‐hydroxyvitamin D
4.6
4.6. Analysis
Comparison 4: Vitamin D (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s), Outcome 6: Change in 25(OH)D (nmol/L)
4.7
4.7. Analysis
Comparison 4: Vitamin D (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s), Outcome 7: Vitamin D sufficiency (≥ 50 nmol/L)
4.8
4.8. Analysis
Comparison 4: Vitamin D (higher dose) + micronutrient(s) versus vitamin D (lower dose) + micronutrient(s), Outcome 8: Rickets (dichotomous)
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD012875

References

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Gallo 2013b {published data only}
    1. Gallo S, Comeau K, Vanstone C, Agellon S, Sharma A, Jones G, et al. Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial. JAMA 2013;309(17):1785-92. [DOI: 10.1001/jama.2013.3404] [PMID: ] - DOI - PubMed
    1. Gallo S, Hazell T, Vanstone CA, Agellon S, Jones G, L'Abbé M, et al. Vitamin D supplementation in breastfed infants from Montréal, Canada: 25-hydroxyvitamin D and bone health effects from a follow-up study at 3 years of age. Osteoporosis International 2016;27(8):2459-66. [DOI: 10.1007/s00198-016-3549-z] [PMID: ] - DOI - PubMed
    1. Gallo S, Rodd C, Vanstone C, Agellon S, Comeau K, Jones G, et al. Vitamin D dose-response study in breast fed infants from Montreal, Canada: 400 IU/day is sufficient to meet the plasma 25-hydroxy vitamin D threshold of 50 nmol/L but not 75 nmol/L by 12 months of age. FASEB Journal 2012;26(Suppl 1):41.4. [DOI: 10.1096/fasebj.26.1_supplement.41.4] - DOI
    1. Gallo S, Rodd C, Vanstone C, Agellon S, L'Abbe M, Khamessan A, et al. Lumbar spine bone mineral density is enhanced in breast fed infants receiving 800 or 1200 IU of vitamin d daily from 4 to 20 weeks of age. Journal of Bone and Mineral Research 2011;26(Suppl 1):S48. [DOI: 10.1002/jbmr.564] [Abstract #1140] - DOI
    1. Gallo S, Rodd C, Weiler H. Vitamin D supplementation during first 12 months of life—reply. JAMA 2013;310(8):853-4. [DOI: 10.1001/jama.2013.124272] [PMID: ] - DOI - PubMed
Gordon 2008 {published data only}
    1. Gordon CM, Williams AL, Feldman HA, May J, Sinclair L, Vasquez A, et al. Treatment of hypovitaminosis D in infants and toddlers. Journal of Clinical Endocrinology & Metabolism 2008;93(7):2716-21. [DOI: 10.1210/jc.2007-2790] [PMC2729207] [PMID: ] - DOI - PMC - PubMed
Greer 1981 {published data only}
    1. Greer FR, Searcy JE, Levin RS, Steichen JJ, Asche PS, Tsang RC. Bone mineral content in breast-fed infants with and without supplemental vitamin D (D). Pediatric Research 1980;14(4, II):500.
    1. Greer FR, Searcy JE, Levin RS, Steichen JJ, Asch PS, Tsang RC. Bone mineral content and serum 25-hydroxyvitamin D concentration in breast-fed infants with and without supplemental vitamin D. Journal of Pediatrics 1981;98(5):696-701. [DOI: 10.1016/s0022-3476(81)80827-x] [PMID: ] - DOI - PubMed
    1. Greer FR, Searcy JE, Levin RS, Steichen JJ, Steichen-Asche PS, Tsang RC. Bone mineral content and serum 25-hydroxyvitamin D concentrations in breast-fed infants with and without supplemental vitamin D: one-year follow-up. Journal of Pediatrics 1982;100(6):919-22. [DOI: 10.1016/s0022-3476(82)80514-3] [PMID: ] - DOI - PubMed
Greer 1989 {published data only}
    1. Greer FR, Marshall S. Bone mineral content, serum vitamin D metabolite concentrations, and ultraviolet B light exposure in infants fed human milk with and without vitamin D2 supplements. Journal of Pediatrics 1989;114(2):204-12. [DOI: 10.1016/s0022-3476(89)80784-x] [PMID: ] - DOI - PubMed
Gupta 2016 {published data only}
    1. CTRI/2013/01/003317. Vitamin D supplementation for severe pneumonia in under-five children [Vitamin D supplementation for severe pneumonia in under-five children: a double blind, randomized placebo controlled trial]. ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=4625&EncHid=&amp... (first received 23 January 2013).
    1. Gupta P, Dewan P, Shah D, Sharma N, Bedi N, Kaur IR, et al. Vitamin D supplementation for treatment and prevention of pneumonia in under-five children: a randomized double-blind placebo controlled trial. Indian Pediatrics 2016;53(11):967-76. [DOI: 10.1007/s13312-016-0970-5] [PMID: ] - DOI - PubMed
Hanson 2011 {published data only}
    1. Hanson C, Armas L, Lyden E, Anderson-Berry A. Vitamin D status and associations in newborn formula-fed infants during initial hospitalization. Journal of the American Dietetic Association 2011;111(12):1836-43. [DOI: 10.1016/j.jada.2011.09.010] [PMID: ] - DOI - PubMed
    1. NCT01042561. Vitamin D status and dose response in infants. clinicaltrials.gov/ct2/show/NCT01042561 (first received 31 December 2009).
Harnot 2017 {published data only (unpublished sought but not used)}
    1. CTRI/2012/05/002621. Appropriate dose of vitamin-D for treatment of vitamin-D deficiency [Appropriate dose of vitamin-D (3L IU or 6L IU) for treatment of vitamin-D deficiency in small children: a double blind randomised trial]. ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=4048&EncHid=&amp... (first received 1 May 2012).
    1. Harnot J, Sanjay V, Singhi S, Sankhyan V, Sachdeva N, Bharti B. Comparison of 300,000 and 600,000 IU oral vitamin-D bolus for vitamin-D deficiency in young children. Indian Journal of Pediatrics 2017;84(2):111-6. [DOI: 10.1007/s12098-016-2233-9] [PMID: ] - DOI - PubMed
Hibbs 2018 {published data only}
    1. Gao Y, Zhang D, Hou B. Vitamin D supplementation in young infants and recurrent wheezing—comment. JAMA 2018;320(16):1708. [DOI: 10.1001/jama.2018.11533] [PMID: ] - DOI - PubMed
    1. Goldsobel A. Effect of vitamin D supplementation on recurrent wheezing in black infants who were born preterm: the D-Wheeze randomized clinical trial. Pediatrics 2018;142(Suppl 4):S250-1. [DOI: 10.1542/peds.2018-2420PPP] - DOI - PMC - PubMed
    1. Hibbs AM, Ross K, Kerns LA, Wagner C, Fuloria M, Groh-Wargo S, et al. Effect of vitamin D supplementation on recurrent wheezing in black infants who were born preterm: the D-Wheeze randomized clinical trial. JAMA 2018;319(20):2086-94; Erratum in: JAMA 2018; 320(6):605. DOI: 10.1001/jama.2018.10664. [DOI: 10.1001/jama.2018.5729] [PMC6583240] [PMID: ] - DOI - PMC - PubMed
    1. Hibbs AM, Wagner CL, Tatsuoka C. Vitamin D supplementation in young infants and recurrent wheezing—reply. JAMA 2018;320(16):1708-9. [DOI: 10.1001/jama.2018.11537] [PMID: ] - DOI - PubMed
    1. Lintonjua AA. Vitamin D reduces risk of recurrent wheezing in premature black infants—comment. Journal of Pediatrics 2018;202:330-3. [DOI: 10.1016/j.jpeds.2018.08.052] [PMID: ] - DOI - PubMed
Holmlund‐Suila 2012 {published data only}
    1. Eudra-CT 2009-015940-40. VIDI-P [Vitamin-D intervention pilotti]. www.clinicaltrialsregister.eu/ctr-search/trial/2009-015940-40/FI (first received 5 October 2009).
    1. Holmlund-Suila E, Viljakainen H, Hytinantti T, Lamberg-Allardt C, Andersson S, Mäkitie O. High-dose vitamin D intervention in infants—effects on vitamin D status, calcium homeostasis, and bone strength. Journal of Clinical Endocrinology & Metabolism 2012;97(11):4139-47. [DOI: 10.1210/jc.2012-1575] [PMID: ] - DOI - PubMed
    1. Holmlund-Suila E, Viljakainen H, Ljunggren Ö, Hytinantti T, Andersson S, Mäkitie O. Fibroblast growth factor 23 concentrations reflect sex differences in mineral metabolism and growth in early infancy. Hormone Research in Paediatrics 2016;85(4):232-41. [DOI: 10.1159/000443988] [PMID: ] - DOI - PubMed
    1. Holmlund-Suila E, Viljakainen H, Ljunggren O, Carlsson E, Hytinantti T, Andersson S, et al. Gender, but not vitamin D supplementation, affects FGF23 concentration in healthy infants. In: Pediatric Academic Societies Annual Meeting; 2015 Apr 25-28; San Diego (CA). 2015. [Abstract #172] [Publication #1522.172] [mydigitalpublication.com/publication/?i=251676]
    1. Holmlund-Suila E. Vitamin D deficiency and supplementation: studies from infancy to young adulthood [Doctoral Thesis]. Helsinki: University of Helsinki, 2016.
Holst‐Gemeiner 1978 {published data only}
    1. Holst-Gemeiner D, Gemeiner M, Pilz I, Swoboda W. Plasma 25-hydroxycholecalciferol after daily vitamin D administration in comparison with massive single-dose prophylaxis [Plasmaspiegel des 25-hydroxycholecalciferols nach tages- und "stossprophylaxe" mit vitamin]. Wiener kKlinische Wochenschrift 1978;90(14):509-12. [PMID: ] - PubMed
Huynh 2017 {published data only}
    1. ACTRN12613001234707. A randomised controlled trial comparing daily (400 international units) and single bolus dosing (50,000 international units) of vitamin D in healthy breastfed infants of vitamin D deficient mothers [A randomised controlled trial evaluating the efficacy and safety of single bolus (50,000 international units) versus daily (400 international units) dosing of vitamin D in healthy breastfed infants of vitamin D deficient mothers]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364356 (first received 9 October 2013).
    1. Bandyopadhyay T, Saini I. Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants—comment. Journal of Paediatrics and Child Health 2017;53(6):615. [DOI: 10.1111/jpc.13534] [PMID: ] - DOI - PubMed
    1. Huynh J, Liew D, Rodda C. Neonatal vitamin D supplementation—reply. Journal of Paediatrics and Child Health 2017;53(7):725-6. [DOI: 10.1111/jpc.13582] [PMID: ] - DOI - PubMed
    1. Huynh J, Lu T, Liew D, Doery J, Tudball R, Jona M, et al. The VINE study: vitamin D in newborns: a randomized controlled trial comparing daily and bolus supplementation in breastfed infants of vitamin D deficient mothers. In: Bone Abstracts. 7th International Conference on Children's Bone Health; 2015 Jun 27-30; Salzburg, Austria. Vol. 4. bioscientifica, 2015. [DOI: 10.1530/boneabs.4.OC19] [Abstract #OC19] - DOI
    1. Huynh J, Lu T, Liew D, Doery JC, Tudball R, Jona M, et al. Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants. Journal of Paediatrics and Child Health 2017;53(2):163-9. [DOI: 10.1111/jpc.13338] [PMID: ] - DOI - PubMed
Jensen 2016 {published data only}
    1. Jensen M, Mailhot G, Alos N, Khamessan A, Rousseau E, White J, et al. A single vitamin D dose of 100,000 IU rapidly raises serum vitamin D levels > 75nmol/l, with no alteration in calcium metabolism biomarkers, in preschool-aged children with asthma. Respirology 2016;21(Suppl 2):181. [DOI: 10.1111/resp.12755] [Abstract #TP 213] - DOI
    1. Jensen ME, Mailhot G, Alos N, Rousseau E, White JH, Khamessan A, et al. Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial. Trials 2016;17(1):353. [DOI: 10.1186/s13063-016-1483-1] [PMC4960871] [PMID: ] - DOI - PMC - PubMed
    1. Jensen ME, Mailhot G, Alos N, White JH, Rousseau E, Khamessan A, et al. A vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial. American Journal of Respiratory and Critical Care Medicine 2015;191:A3360. [B53 new aspects of pediatric asthma, thematic poster session] [www-atsjournals-org.proxy.library.cornell.edu/doi/pdf/10.1164/ajrccm-con...
    1. NCT01999907. Vitamin D to reduce colds and asthma attacks in young children (DIVA-pilot) [Vitamin D vs placebo in the prevention of viral-induced exacerbations in preschoolers with asthma: a pilot RCT]. clinicaltrials.gov/ct2/show/NCT01999907 (first received 25 November 2013).
Kislal 2008 {published data only}
    1. Kislal FM, Dilmen U. Effect of different doses of vitamin D on osteocalcin and deoxypyridinoline in preterm infants. Pediatrics International 2008;50(2):204-7. [DOI: 10.1111/j.1442-200X.2008.02553.x] - DOI - PubMed
Lagomarsino 1996 {published data only}
    1. Lagomarsino FE, Arnaiz GP, Vial CP, Heusser RF, Cantwell AM, Johnson PMC, et al. Effects of two forms of vitamin D supplementation on bone metabolism and infant growth [Efecto de dos formas de suplementación de vitamina D en el crecimiento y metabolismo óseo del lactante]. Chilean Journal of Pediatrics [Revista Chilena de Pediatría] 1996;67(5):219-23. [DOI: 10.4067/S0370-41061996000500005 ]
Lava 2011 {published data only}
    1. Lava SAG, Caccia G, Osmetti-Gianini S, Simonetti GD, Milani GP, Falesi M, et al. Acceptance of two liquid vitamin D₃ formulations among mothers with newborn infants: a randomized, single-blind trial. European Journal of Pediatrics 2011;170(12):1559-62. [DOI: 10.1007/s00431-011-1477-7] [PMID: ] - DOI - PubMed
Manaseki Holland 2010 {published data only (unpublished sought but not used)}61245920
    1. ISRCTN61245920. The effect of vitamin D supplementation at diagnosis of pneumonia upon response to treatment. www.isrctn.com/ISRCTN61245920 (first received 27 February 2007). [DOI: 10.1186/ISRCTN61245920] - DOI
    1. Manaseki-Holland S, Qader G, Isaq Masher M, Bruce J, Zulf Mughal M, Chandramohan D, et al. Effects of vitamin D supplementation to children diagnosed with pneumonia in Kabul: a randomised controlled trial. Tropical Medicine & International Health 2010;15(10):1148-55. [DOI: 10.1111/j.1365-3156.2010.02578.x] [PMID: ] - DOI - PubMed
    1. Maroof Z, Manaseki-Holland S, Masher MI, Bruce J. Effects of vitamin D supplementation to children admitted to hospital for pneumonia in Kabul: a randomised controlled trial. Tropical Medicine & International Health 2009;14(Suppl 2):145. [DOI: 10.1111/j.1365-3156.2009.02354_1.x] [Abstract #5.1-138] - DOI - PubMed
Manaseki‐Holland 2012 {published data only}
    1. Aluisio AR, Maroof Z, Chandramohan D, Bruce J, Masher MI, Manaseki-Holland S, et al. Risk factors associated with recurrent diarrheal illnesses among children in Kabul, Afghanistan: a prospective cohort study. Plos One 2015;10(2):e0116342. [DOI: 10.1371/journal.pone.0116342] [PMC4332656] [PMID: ] - DOI - PMC - PubMed
    1. Manaseki-Holland S, Maroof Z, Bruce J, Mughal MZ, Masher MI, Bhutta ZA, et al. Effect on the incidence of pneumonia of vitamin D supplementation by quarterly bolus dose to infants in Kabul: a randomised controlled superiority trial. Lancet 2012;379(9824):1419-27. [DOI: 10.1016/S0140-6736(11)61650-4] [PMC3348565] [PMID: ] - DOI - PMC - PubMed
    1. Maroof Z, Manaseki-Holland S, Chandramohan D, Bhutta Z, Mughal Z, Bruce J, et al. RCT methodology, population profile and pneumonia rates in socio-economically deprived infants of Kabul: from an RCT investigating the effects of vitamin D supplementation on the incidence of infant pneumonia. Tropical Medicine & International Health 2009;14(Suppl 2):145-6. [DOI: 10.1111/j.1365-3156.2009.02354_1.x] [Abstract #5.1-139] - DOI
    1. Maroof Z. The Effects of Vitamin D Supplementation on the Incidence of Pneumonia in Infants and Young Children in Kabul, Afghanistan: A Double Blind Randomized Controlled Trial [PhD thesis]. London (UK): London School of Hygiene & Tropical Medicine, 2011.
    1. NCT00548379. Kabul vitamin D supplementation trial [The effect of vitamin D supplementation on the incidence of pneumonia in children in Afghanistan: a randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT00548379 (first received 23 October 2007).
Marchisio 2013 {published data only}
    1. Marchisio P, Consonni D, Baggi E, Zampiero A, Bianchini S, Terranova L, et al. Vitamin D supplementation reduces the risk of acute otitis media in otitis-prone children. Pediatric Infectious Disease Journal 2013;32(10):1055-60. [DOI: 10.1097/INF.0b013e31829be0b0] [PMID: ] - DOI - PubMed
Mathur 2016 {published data only}
    1. CTRI/2018/02/012058. Evaluating sufficiency of oral vitamin D dose in babies with birth weight less than 1500 g born prematurely before 37 weeks of gestation [Assessment of adequacy of supplementation of vitamin D in very low birth weight pre term neonates]. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6491&EncHid=&us... (first received 21 February 2018).
    1. Mathur NB, Saini A, Mishra TK. Assessment of adequacy of supplementation of vitamin D in very low birth weight preterm neonates: a randomized controlled trial. Journal of Tropical Pediatrics 2016;62(6):429-35. [DOI: 10.1093/tropej/fmv110] [PMID: ] - DOI - PubMed
Mittal 2014 {published data only}
    1. Jacobs B. Is single oral dose of 300,000 IU vitamin D3 adequate for treatment of nutritional rickets? Indian Pediatrics 2014;51(4):260-1. [PMID: ] - PubMed
    1. Mittal H, Rai S, Shah D, Madhu SV, Mehrotra G, Malhotra RK, et al. 300,000 IU or 600,000 IU of oral vitamin D3 for treatment of nutritional rickets: a randomized controlled trial. Indian Pediatrics 2014;51(4):265-72. [DOI: 10.1007/s13312-014-0399-7] [PMID: ] - DOI - PubMed
    1. Pettifor JM. How should we manage vitamin D deficiency rickets? Indian Pediatrics 2014;51(4):259-60. [DOI: 10.1007/s13312-014-0388-x] [PMID: ] - DOI - PubMed
Mittal 2018 {published data only}
    1. CTRI/2017/02/007791. A study on children suffering from nutritional rickets aged 6 months to 5 years comparing a lower dose of vitamin D given as a single oral dose for treatment (90,000 IU) with the standard dose (3,00,00 IU) [To compare the efficacy of 90,000 IU and 3,00,00 IU oral single dose vitamin D for treatment of nutritional rickets in children aged 6 months to 5 years—a randomized controlled trial]. ctri.nic.in/Clinicaltrials/showallp.php?mid1=10170&EncHid=&userN... (first received 6 February 2017).
    1. Mittal M, Yadav V, Khadgawat R, Kumar M, Sherwani P. Efficacy and safety of 90,000 IU versus 300,000 IU single dose oral vitamin D in nutritional rickets: a randomized controlled trial. Indian Journal of Endocrinology and Metabolism 2018;22(6):760-5. [DOI: 10.4103/ijem.IJEM_84_18] [PMC6330863] [PMID: ] - DOI - PMC - PubMed
    1. Mittal M, Yadav V, Khadgawat R, Kumar M, Sherwani P. Single dose oral vitamin D3 90,000 IU is safe and as effective as 300,000 IU in treatment of nutritional rickets in children. EBSCO Abstracts 2016;21:51.
Moodley 2015 {published data only}
    1. Moodley A, Qin M, Spector S. Vitamin D supplementation at birth boosts immune response to Bacille Calmette Guerin (BCG) in infants. In: Pediatric Academic Societies Annual Meeting; 2013 May 4-7; Washington (DC). 2013.
    1. Moodley A, Qin M, Spector S. Vitamin D supplementation at birth corrects vitamin D deficiency in infants born in Tijuana, Mexico. In: Pediatric Academic Societies Annual Meeting; 2013 May 4-7; Washington (DC). 2013.
    1. Moodley A, Spector SA. Single high-dose vitamin D at birth corrects vitamin D deficiency in infants in Mexico. International Journal of Food Sciences and Nutrition 2015;66(3):336-41. [DOI: 10.3109/09637486.2014.992006] [PMC4648545] [PMID: ] - DOI - PMC - PubMed
    1. Moodley A, Spector SA. Single high-dose vitamin D at birth corrects vitamin D deficiency in infants in Mexico. International Journal of Food Sciences and Nutrition 2015;66(3):336-41. [DOI: 10.3109/09637486.2014.992006] [PMC4648545] [PMID: ] - DOI - PMC - PubMed
    1. NCT01288950. Vitamin D supplementation enhances immune response to Bacille-Calmette-Guerin (BCG) vaccination in infants (BCG-25-D) [Vitamin D supplementation enhances immune response to BCG vaccination in infants]. clinicaltrials.gov/ct2/show/NCT01288950 (first received 1 February 2011).
Morawa 1963 {published data only}
    1. Morawa A. Prevention of Rickets in Premature Infants [Beitrag zur Rachitisprophylaxe bei Fruhgeborenen] [Doctoral Thesis]. Gelsenkirchen: Rheinische Friedrich-Wilhelms Universität zu Bonn, 1963.
Natarajan 2014 {published data only}
    1. CTRI/2012/02/002459. Efficacy of different regimens of vitamin D supplementation in preterm infants - a randomized double blind trial. www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=3299&EncHid=... (first received 27 February 2012).
    1. Kumar C, Sankar M, Agarwal R, Pratap O, Jain V, Gupta N. Daily vitamin D supplementation with 800 IU vs 400 IU in preterm infants: a randomized trial. In: Pediatric Academic Societies 2013 Annual Meeting; 2013 May 04-07; Washington (DC). 2013.
    1. Natarajan CK, Sankar MJ, Agarwal R, Pratap OT, Jain V, Gupta N, et al. Trial of daily vitamin D supplementation in preterm infants. Pediatrics 2014;133(3):e628-34. [DOI: 10.1542/peds.2012-3395] [PMID: ] - DOI - PubMed
Pehlivan 2003 {published data only}
    1. Pehlivan I, Hatun Ş, Aydoǧan M, Babaoǧlu K, Gökalp AS. Maternal vitamin D deficiency and vitamin D supplementation in healthy infants. Turkish Journal of Pediatrics 2003;45(4):315-20. [PMID: ] - PubMed
Ponnapakkam 2010 {published data only}
    1. Bradford EM, Gensure R, Ponnapakkam I. Vitamin D supplementation in the breastfed infants: preliminary results of a prospective trial. Journal of Investigative Medicine 2010;58(2):448. [DOI: 10.1002/jbmr.5650231305] [Abstract #327] - DOI
    1. Ponnapakkam T, Bradford E, Gensure R. A treatment trial of vitamin D supplementation in breast-fed infants: universal supplementation is not necessary for rickets prevention in Southern Louisiana. Clinical Pediatrics 2010;49(11):1053-60. [DOI: 10.1177/0009922810376320] [PMID: ] - DOI - PubMed
    1. Ponnapakkam T, Bradford E, Gensure R. Vitamin D supplementation in breastfed infants: results of a prospective trial in the Southern United States. Journal of Bone and Mineral Research 2010;25(Suppl 1):S232. [DOI: 10.1002/jbmr.5650251304] [Abstract #SU0026] - DOI
    1. Ponnapakkam T, Bradford E, Gensure R. Vitamin D supplementation in the breastfed infants: preliminary results of a prospective trial. Hormone Research 2009;72(Suppl 3):198. [DOI: 10.1159/000239668)] [Abstract #LB-PO1-007] - DOI
    1. Ponnapakkam T, Bradford E, Gensure RC. Vitamin D supplementation in breast fed infants: a prospective trial-recruitment problem encountered along the way. Journal of Bone and Mineral Research 2008;23(Suppl 1):S371. [DOI: 10.1002/jbmr.5650231305] [Abstract #SU500] - DOI
Principi 2013 {published data only}
    1. Principi N, Eposito S. Vitamin D and influenza vaccination—reply. Human Vaccines & Immunotherapeutics 2013;9(5):976. [DOI: 10.4161/hv.23848] [PMC3899165] [PMID: ] - DOI - PMC - PubMed
    1. Principi N, Marchisio P, Terranova L, Zampiero A, Baggi E, Daleno C, et al. Impact of vitamin D administration on immunogenicity of trivalent inactivated influenza vaccine in previously unvaccinated children. Human Vaccines & Immunotherapeutics 2013;9(5):969-74. [DOI: 10.4161/hv.23540] [PMC3899163] [PMID: ] - DOI - PMC - PubMed
    1. Wiwanitkit V. Vitamin D and influenza vaccination—comment. Human Vaccines & Immunotherapeutics 2013;9(5):975. [DOI: 10.4161/hv.23847] [PMC3899164] [PMID: ] - DOI - PMC - PubMed
Rao 2016 {published data only}
    1. Rao YK, Midha T, Singh S, Bajpai A, Tilak A. Increment in vitamin D level and bone mineral accrual in children with vitamin D deficiency. Korean Journal of Pediatrics 2016;59(7):292-7. [DOI: 10.3345/kjp.2016.59.7.292] [PMC5007424] [PMID: ] - DOI - PMC - PubMed
Rianthavorn 2013 {published and unpublished data}
    1. Rianthavorn P, Boonyapapong P. Ergocalciferol decreases erythropoietin resistance in children with chronic kidney disease stage 5. Pediatric Nephrology 2013;28(8):1261-6. [DOI: 10.1007/s00467-013-2431-x] [PMID: ] - DOI - PubMed
Robinson 1981 {published data only}
    1. Robinson MJ, Merrett AL, Tetlow VA, Compston JE. Plasma 25-hydroxyvitamin D concentrations in preterm infants receiving oral vitamin D supplements. Archives of Disease in Childhood 1981;56(2):144-5. [DOI: 10.1136/adc.56.2.144] [PMC1627110] [PMID: ] - DOI - PMC - PubMed
Rodd 2011 {published data only (unpublished sought but not used)}
    1. NCT00846677. Study comparing two vitamin D supplements for infants: liquid versus D-strips [A randomized, open-label, cross-over study comparing two vitamin D supplements for infants: liquid versus D-strips]. clinicaltrials.gov/ct2/show/study/NCT00846677 (first received 17 February 2009).
    1. Rodd C, Jean-Philippe S, Vanstone C, Weiler H. Comparison of 2 vitamin D supplementation modalities in newborns: adherence and preference. Applied Physiology, Nutrition, and Metabolism 2011;36(3):414-18. [DOI: 10.1139/h11-018] [PMID: ] - DOI - PubMed
    1. Rodd C, Jean-Philippe S, Vanstone C, Weiler H. Comparison of parent-perceived acceptance of two vitamin D supplementation modalities in newborn infants. Pediatrics and Child Health 2010;15(Suppl A):68A-9A. [DOI: 10.1093/pch/15.suppl_A.68Ab] [Abstract #183] - DOI
Rosendahl 2018 {published data only}
    1. Enlund-Cerullo M, Koljonen L, Holmlund-Suila E, Hauta-Alus H, Rosendahl J, Valkama S, et al. Genetic variation of the vitamin D binding protein affects vitamin D status and response to supplementation in infants. Journal of Clinical Endocrinology & Metabolism 2019;104(11):5483-98. [DOI: 10.1210/jc.2019-00630] [PMID: ] - DOI - PubMed
    1. Enlund-Cerullo M, Valkama S, Holmlund-Suila E, Rosendahl J, Hauta-Alus H, Viljakainen H, et al. No severe hypercalcemia during a 12-month high-dose vitamin D intervention in infants. Hormone Research in Paediatrics 2016;86(Suppl 1):170. [DOI: 10.1159/000449142] [Abstract #P1-P117] - DOI - PubMed
    1. Helve O, Viljakainen H, Homlund-Suila E, Rosendahl J, Hauta-lus H, Enlund-Cerullo M, et al. Towards evidence-based vitamin D supplementation in infants: vitamin D intervention in infants (VIDI)—study design and methods of a randomised controlled double-blinded intervention study. BMC Pediatrics 2017;17(1):91. [DOI: 10.1186/s12887-017-0845-5] [PMC5372327] [PMID: ] - DOI - PMC - PubMed
    1. Li F, Lin X, Yuan LQ. Vitamin D3 supplementation and bone health—comment. JAMA 2018;172(12):1202. [DOI: 10.1001/jamapediatrics.2018.3349] [PMID: ] - DOI - PubMed
    1. NCT01723852. Vitamin D intervention in infants (VIDI) [Vitamin D intervention in infants]. clinicaltrials.gov/ct2/show/NCT01723852 (first received 6 November 2012).
Rueter 2019 {published data only}
    1. ACTRN12606000281594. Infant fish oil study [The immunomodulatory effects of omega-3 polyunsaturated fatty acids: role in allergy prevention]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=1438 (first received 29 June 2006).
    1. Rueter K, Jones A, Siafarikas A, Bear N, Lim EM, Noakes P, et al. The effect of vitamin D and UV-light exposure on immune development in infancy. Allergy: European Journal of Allergy & Clinical Immunology 2019;74(Suppl 106):241. [DOI: 10.1111/all.13959] [Abstract #PD0430] - DOI - PubMed
    1. Rueter K, Jones A, Siafarikas A, Lim EM, Prescott SL, Palmer DJ. The influence of vitamin D and UV-light exposure on the developing immune phenotype in infancy. Internal Medicine Journal 2016;46(Suppl 4):21-2. [DOI: 10.1111/imj.55_13197] [Abstrcat #ASCIA-P55] - DOI
    1. Rueter K, Jones AP, Siafarikas A, Lim EM, Bear N, Noakes PS, et al. Direct infant UV light exposure is associated with eczema and immune development. Journal of Allergy and Clinical Immunology 2019;143(3):1012-20.e2. [DOI: 10.1016/j.jaci.2018.08.037] [PMID: ] - DOI - PubMed
    1. Rueter K, Jones AP, Siafarikas A, Lim EM, Clarke MW, Noakes PS, et al. The effect of vitamin D and sunlight exposure on immune development in the first 6 months of life. Internal Medicine Journal 2018;48(Suppl 6):29. [DOI: 10.1111/imj.8_14078] [Abstract #R8] - DOI
Saad 2015 {published data only (unpublished sought but not used)}
    1. Saad K, Abd Aziz NHR, El-Houfey AA, El-Asheer O, Mohamed SAA, Ahmed AE, et al. Trial of vitamin D supplementation in infants with bronchiolitis: a randomized, double-blind, placebo-controlled study. Pediatric Allergy, Immunology, and Pulmonology 2015;28(2):102-6. [DOI: 10.1089/ped.2015.0492] - DOI
Saleem 2018 {published data only}
    1. NCT03170479. Developmental screening and nutritional intervention of severe acute malnourished children in Southern Punjab, Pakistan. clinicaltrials.gov/ct2/show/NCT03170479 (first received 16 October 2016).
    1. Saleem J, Zakar R, Zakar MZ, Belay M, Rowe M, Timms PM, et al. High-dose vitamin D3 in the treatment of severe acute malnutrition: a multicenter double-blind randomized controlled trial. American Journal of Clinical Nutrition 2018;107(5):725-33. [DOI: 10.1093/ajcn/nqy027] [PMID: ] - DOI - PubMed
Sánchez‐Armendáriz 2018 {published and unpublished data}
    1. Sánchez-Armendáriz K, García-Gil A, Romero CA, Contreras-Ruiz J, Karam-Orante M, Balcazar-Antonio D, et al. Oral vitamin D3 5000 IU/day as an adjuvant in the treatment of atopic dermatitis: a randomized control trial. International Journal of Dermatology 2018;57(12):1516-20. [DOI: 10.1111/ijd.14220] [PMID: ] - DOI - PubMed
Sarhan 2019 {published data only (unpublished sought but not used)}
    1. NCT03799406. Vitamin D supplementation for acute bronchiolitis [Does oral vitamin D supplementation in Egyptian infants with acute bronchiolitis improve the outcome? A double blind randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT03799406 (first received 29 December 2018).
    1. Sarhan AA, Saeed NM, Mostafa AA, Osman AM. Vitamin D supplementation for acute bronchiolitis: a double-blind randomized controlled trial. Alexandria Journal of Pediatrics 2019;32(2):61-7. [DOI: 10.4103/AJOP.AJOP_28_19] - DOI
Shajari 2009 {published data only}
    1. Shajari A, Shakiba M, Nourani F, Zaki M, Kheirandish M. Urinary calcium/creatinine ratio with different dosages of vitamin D3 prophylaxis in infants. Iran Journal of Pediatrics 2009;19(2):159-63. [www.bioline.org.br/pdf?pe09025]
Shakiba 2010 {published data only}
    1. Shakiba M, Sadr S, Nefei Z, Mozaffari-Khosravi H, Lotfi MH, Bemanian MH. Combination of bolus dose vitamin D with routine vaccination in infants: a randomised trial. Singapore Medical Journal 2010;51(5):440-5. [PMID: ] - PubMed
Shedeed 2012 {published data only}
    1. Shedeed SA. Vitamin D supplementation in infants with chronic congestive heart failure. Pediatric Cardiology 2012;33(5):713-9. [DOI: 10.1007/s00246-012-0199-6] [PMID: ] - DOI - PubMed
Siafarikas 2011 {published data only}
    1. ACTRN12609000919213. Optimizing vitamin D supplementation and sun exposure for breastfed infants in Berlin, Germany [An assessment of the minimal amount of vitamin D supplementation and sun exposure required to provide a sufficient vitamin D status in breastfed infants during their first 6 weeks of life]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=320733 (first received 22 October 2009).
    1. Siafarikas A, Piazena H, Feister U, Bulsara MK, Meffert H, Hesse V. Randomised controlled trial analysing supplementation with 250 versus 500 units of vitamin D3, sun exposure and surrounding factors in breastfed infants. Archives of Disease in Childhood 2011;96(1):91-5. [DOI: 10.1136/adc.2009.178301] [PMID: ] - DOI - PubMed
Singh 2018a {published data only}
    1. Singh H, Maria A, Shukla A, Sharma N, Mani K, Das MK. Relation of vitamin D supplementation, up to six months of age with total and bone specific alkaline phosphatase: a randomised control trial. Journal of Clinical and Diagnostic Research 2018;12(10):SC01-5. [DOI: 10.7860/JCDR/2018/34751.12095] - DOI
    1. Singh H, Shukla A, Maria A, Mani K. Daily supplementation with 400 IU vitamin D in term breast fed infants from 0-6 months and changes in total and bone specific alkaline phosphatase--an RCT. European Journal of Pediatrics 2017;176(11):1528. [DOI: 10.1007/s00431-017-2979-8] [Abstract #456] - DOI
Singh 2019 {published data only}
    1. Singh N, Kamble D, Mahantshetti NS. Effect of vitamin D supplementation in the prevention of recurrent pneumonia in under-five children. Indian Journal of Pediatrics 2019;86(12):1105-11. [DOI: 10.1007/s12098-019-03025-z] [PMID: ] - DOI - PubMed
Somnath 2017 {published data only}
    1. CTRI/2014/09/005032. Vitamin D in pneumonia in under five children--a randomized controlled trial [Outcome of severe lower respiratory infection in under-five children with vitamin D supplementation]. www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=9095&EncHid=... (first received 18 September 2014).
    1. Somnath SH, Biswal N, Chandrasekaran V, Jagadisan B, Bobby Z. Therapeutic effect of vitamin D in acute lower respiratory infection: a randomized controlled trial. Clinical Nutrition ESPEN 2017;20:24-8. [DOI: 10.1016/j.clnesp.2017.02.003] [PMID: ] - DOI - PubMed
Specker 1992 {published data only}
    1. Specker BL, Ho ML, Oestreich A, Yin TA, Shui QM, Chen XC, et al. Prospective study of vitamin D supplementation and rickets in China. Journal of Pediatrics 1992;120(5):733-9. [DOI: 10.1016/s0022-3476(05)80236-7] [PMID: ] - DOI - PubMed
Stögmann 1985 {published data only}
    1. Stögmann W, Sacher M, Blümel P, Woloszczuk W. Vitamin D deficiency rickets: single-dose therapy versus continuous therapy. Padiatrie und Padologie 1985;20(4):385-92. [PMID: ] - PubMed
Tang 2019 {published and unpublished data}
    1. ChiCTR-INR-16009235. Effects of vitamin D in children with juvenile idiopathic arthritis (JIA) about the level of serum interleukin and tumor necrosis factor alpha [维生素D对幼年特发性关节炎（JIA）患儿血清白介素及肿瘤坏死因子α水平的影响]. www.chictr.org.cn/hvshowproject.aspx?id=10921 (first received 21 September 2016).
    1. Tang T, Zhang Y, Luo C, Liu M, Xu L, Tang X. Adjunctive vitamin D for the treatment of active juvenile idiopathic arthritis: an open-label, prospective, randomized controlled trial. Experimental and Therapeutic Medicine 2019;18(6):4921-6. [DOI: 10.3892/etm.2019.8133] [PMC6880388] [PMID: ] - DOI - PMC - PubMed
Tergestina 2016 {published data only}
    1. CTRI/2012/11/003154. Comparison of the efficacy of two regimens of vitamin D supplementation in preventing vitamin D deficiency among preterm infants [A randomized double blind controlled trial comparing two regimens of vitamin D supplementation in preterm neonates]. www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=5533&EncHid=... (first received 29 November 2012).
    1. Tergestina M, Rebekah G, Job V, Simon A, Thomas N. A randomized double-blind controlled trial comparing two regimens of vitamin D supplementation in preterm neonates. Journal of Perinatology 2016;36(9):763-7. [DOI: 10.1038/jp.2016.70] [PMID: ] - DOI - PubMed
Thacher 2014 {published and unpublished data}
    1. NCT00949832. Vitamin D and genetics in nutritional rickets. clinicaltrials.gov/ct2/show/NCT00949832 (first received 29 July 2009).
    1. Thacher TD, Fischer PR, Pettifor JM. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial. Archives of Disease in Childhood 2014;99(9):807-11. [DOI: 10.1136/archdischild-2013-305275] [PMC4145444] [PMID: ] - DOI - PMC - PubMed
Tomimoto 2018 {published data only (unpublished sought but not used)}
    1. JMA-IIA00243. A study of vitamin D supplementation in breast fed infant with vitamin D deficiency. dbcentre3.jmacct.med.or.jp/JMACTR/App/JMACTRS06/JMACTRS06.aspx?seqno=5784 (first received 04 February 2016).
    1. Tomimoto K. A study on appropriate vitamin D supplementation in vitamin D-deficient breastfed infants. Journal of the Japan Pediatric Society 2018;122(11):1683-91. [www.jpeds.or.jp/journal/abstract/122-11e.html]
Trilok‐Kumar 2011 {published and unpublished data}
    1. Kumar GT, Sachdev HPS, Chellani H, Rehman AM, Singh V, Arora H, et al. Effect of weekly vitamin D supplements to Indian low birth weight term infants on mortality, morbidity, and growth in the first 6 months of life: a randomised controlled trial. In: Proceedings of the Nutrition Society. Vitamins in Early Development and Healthy Ageing: Impact on Infectious and Chronic Disease. Joint Irish Section and American Society for Nutrition Meeting, 70th Anniversary. 2011 Jun 15-17. Cork. Vol. 70. 2011:E98. [DOI: 10.1017/S0029665111001388] - DOI
    1. NCT00415402. Effect of vitamin D supplementation on health of low birth weight infants (DIVIDS) [Randomised controlled trial to evaluate the preventive effect on mortality and serious morbidity/ Hospitalisations of daily vitamin D supplements in small for gestational age term infants]. clinicaltrials.gov/ct2/show/NCT00415402 (first received 21 December 2006).
    1. Trilok-Kumar G, Arora H, Rajput M, Chellani H, Singh V, Raynes J, et al. Effect of vitamin D supplementation of low birth weight term Indian infants from birth on cytokine production at 6 months. European Journal of Clinical Nutrition 2012;66(6):746-50. [DOI: 10.1038/ejcn.2012.33] [PMID: ] - DOI - PubMed
    1. Trilok-Kumar G, Kaur M, Rehman AM, Arora H, Rajput MM, Chugh R, et al. Effects of vitamin D supplementation in infancy on growth, bone parameters, body composition and gross motor development at age 3-6 years: follow-up of a randomized controlled trial. International Journal of Epidemiology 2015;44(3):894-905. [DOI: 10.1093/ije/dyv116] [PMID: ] - DOI - PubMed
    1. Trilok-Kumar G, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, et al. Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial. BMJ 2011;342:d2975. [DOI: 10.1136/bmj.d2975] [PMC3104477] [PMID: ] - DOI - PMC - PubMed
Willi 1959 {published data only}
    1. Willi H. On the prophylaxis of rickets in premature infants [Zur Prophylaxe der Frühgeborenenrachitis]. Helvetica Paediatrica Acta 1959;14:351-71. [PMID: ] - PubMed
Zeghoud 1994 {published data only}
    1. Zeghoud F, Ben-Mekhbi H, Djeghri N, Garabédian M. Vitamin D prophylaxis during infancy: comparison of the long-term effects of three intermittent doses (15, 5, or 2.5 mg) on 25-hydroxyvitamin D concentrations. American Journal of Clinical Nutrition 1994;60(3):393-6. [DOI: 10.1093/ajcn/60.3.393] [PMID: ] - DOI - PubMed
Ziegler 2014 {published data only}
    1. NCT00494104. Prevention of vitamin D deficiency [Prevention of vitamin D deficiency in breastfed infants]. clinicaltrials.gov/ct2/show/NCT00494104 (first received 28 June 2007).
    1. Ziegler EE, Koo WW, Nelson SE, Jeter JM. Lack of effect of graded doses of vitamin D on bone metabolism of breastfed infants. Journal of Clinical Nutrition and Metabolism 2017;1(1):105. [PMC5744599] [PMID: ] - PMC - PubMed
    1. Ziegler EE, Nelson SE, Jeter JM. Vitamin D supplementation of breastfed infants: a randomized dose-response trial. Pediatric Research 2014;76(2):177-83. [DOI: 10.1038/pr.2014.76] [PMC4104134] [PMID: ] - DOI - PMC - PubMed

References to studies excluded from this review

Abrams 2013 {published data only (unpublished sought but not used)}
    1. Abrams S, Hawthorne K, Chen Z. Vitamin D3 supplementation leads to increased total calcium absorption in 4 to 8 yr old children. FASEB Journal 2012;26(Suppl 1):365.1. [DOI: 10.1096/fasebj.26.1_supplement.365.1] - DOI
    1. Abrams SA, Hawthorne KM, Chen Z. Supplementation with 1000 IU vitamin D/d leads to parathyroid hormone suppression, but not increased fractional calcium absorption, in 4-8-y-old children: a double-blind randomized controlled trial. American Journal of Clinical Nutrition 2013;97(1):217-23. [DOI: 10.3945/ajcn.112.046102] [PMC3522137] [PMID: ] - DOI - PMC - PubMed
    1. NCT00868738. Evaluation of calcium, vitamin D, magnesium, and zinc absorption in children [Evaluation of calcium, vitamin D, magnesium, and zinc absorption in healthy children 4 to 8 years of age]. clinicaltrials.gov/ct2/show/NCT00868738 (first received 24 March 2009).
Atkinson 2017 {published data only (unpublished sought but not used)}
    1. Atkinson MA, Juraschek SP, Bertenthal MS, Detrick B, Furth SL, Miller ER 3rd. Pilot study of the effect of cholecalciferol supplementation on hepcidin in children with chronic kidney disease: results of the D-fense trial. Pediatric Nephrology 2017;32(5):859-68. [DOI: 10.1007/s00467-016-3563-6] [PMC5735842] [PMID: ] - DOI - PMC - PubMed
    1. NCT01532349. Vitamin D as a modifier of serum hepcidin in children with chronic kidney disease (D-fense) [Cholecalciferol as a modifier of serum hepcidin in children with chronic kidney disease]. clinicaltrials.gov/ct2/show/NCT01532349 (first received 8 February 2012).
Camargo 2014 {published data only (unpublished sought but not used)}
    1. Camargo CA Jr, Ganmaa D, Sidbury R, Erdenedelger Kh, Radnaakhand N, Khandsuren B. Randomized trial of vitamin D supplementation for winter-related atopic dermatitis in children. Journal of Allergy and Clinical Immunology 2014;134(4):831-5.e1. [DOI: 10.1016/j.jaci.2014.08.002] [PMID: ] - DOI - PubMed
    1. NCT00879424. Vitamin D supplementation in childhood atopic dermatitis [Randomized trial of vitamin D supplementation in winter-related, childhood atopic dermatitis]. clinicaltrials.gov/ct2/show/NCT00879424 (first received 9 April 2009).
Dehbroki 2019 {published data only (unpublished sought but not used)}
    1. Dehbokri N, Noorazar G, Ghaffari A, Mehdizadeh G, Sarbakshsh P, Ghaffary S. Effect of vitamin D treatment in children with attention-deficit hyperactivity disorder. World Journal of Pediatrics 2019;15(1):78-84. [DOI: 10.1007/s12519-018-0209-8] [PMID: ] - DOI - PubMed
    1. IRCT2017012826998N2. Effect of vitamin D deficiency treatment on children with attention deficit hyperactivity disorder (ADHD). en.irct.ir/trial/22244 (first received 1 March 2017).
Galli 2015 {published data only (unpublished sought but not used)}
    1. Galli E, Rocchi L, Carella R, Giampietro PG, Panei P, Meglio P. Serum vitamin D levels and vitamin D supplementation do not correlate with the severity of chronic eczema in children. European Annals of Allergy and Clinical Immunology 2015;47(2):41-7. [www.eurannallergyimm.com/cont/journals-articles/358/volume-serum-vitamin... [PMID: ] - PubMed
Gottschlich 2017 {published data only (unpublished sought but not used)}
    1. Gottschlich MM, Mayes T, Khoury J, Kagan R. Differential effects of three vitamin D supplementation practices on clinical outcome postburn. Journal of Burn Care & Research 2011;32(Suppl 2):S73. [DOI: 10.1097/BCR.0b013e318211ec89] - DOI
    1. Gottschlich MM, Mayes T, Khoury J, Kagan RJ. Clinical trial of vitamin D2 vs D3 supplementation in critically ill pediatric burn patients. JPEN. Journal of Parenteral and Enteral Nutrition 2017;41(3):412-21. [DOI: 10.1177/0148607115587948] [PMID: ] - DOI - PubMed
    1. Mayes T, Gottschlich MM, Brunner C, Khoury J, Kagan, RJ. Long-term follow-up fracture incidence in children receiving vitamin D supplementation during the acute phase postburn. Journal of Burn Care & Research 2012;33(Suppl 1):S82. [DOI: 10.1097/BCR.0b013e3182508c98] - DOI
    1. Mayes T, Gottschlich MM, Khoury J, Kagan RJ. Investigation of bone health subsequent to vitamin D supplementation in children following burn injury. Nutrition in Clinical Practice 2015;30(6):830-7. [DOI: 10.1177/0884533615587720] [PMID: ] - DOI - PubMed
    1. NCT00536276. Evaluation of vitamin D status in children with acute burns (VitaminD) [Vitamin D deficiency in acutely injured pediatric burn patients: incidence, etiology, metabolic sequelae and prevention]. clinicaltrials.gov/ct2/show/NCT00536276 (first received 25 September 2007).
Hamidieh 2016 {published data only (unpublished sought but not used)}
    1. Hamidieh AA, Sherafatmand M, Mansouri A, Hadjibabaie M, Ashouri A, Jahangard-Rafsanjani Z, et al. Calcitriol for oral mucositis prevention in patients with Fanconi anemia undergoing hematopoietic SCT: a double-blind, randomized, placebo-controlled trial. American Journal of Therapeutics 2016;23(6):e1700-8. [DOI: 10.1097/MJT.0000000000000269] [PMID: ] - DOI - PubMed
    1. IRCT201307141030N15. Calcitriol in prevention of mucositis in patients with Fanconi anemia undergoing hematopoietic stem cell transplantation [Efficacy of calcitriol in prevention of high dose chemotherapy induced mucositis in patients with Fanconi anemia undergoing hematopoietic stem cell transplantation]. en.irct.ir/trial/24 (first received 16 July 2013).
Homola 2011 {published data only (unpublished sought but not used)}
    1. Homola L, Holcikova A, Mikolasek P, Pavelka J. Vitamin D supplementation in children with cystic fibrosis: sunshine, cholecalciferol and ergocalciferol. Journal of Cystic Fibrosis 2011;10(Suppl 1):S76. [DOI: 10.1016/S1569-1993(11)60315-9] [Abstract #302] - DOI
Kakalia 2011 {published data only (unpublished sought but not used)}
    1. Kakalia S, Sochett E, Assor E, Arneson C, Stephens D, Read S, et al. Vitamin D supplementation and CD4 count in HIV infected children. Canadian Journal of Infectious Diseases and Medical Microbiology 2010;21(3 Suppl B):53B. [Abstract #P152] [Article ID 923563]
    1. Kakalia S, Sochett EB, Stephens D, Assor E, Read SE, Bitnun A. Vitamin D supplementation and CD4 count in children infected with human immunodeficiency virus. Journal of Pediatrics 2011;159(6):951-7. [DOI: 10.1016/j.jpeds.2011.06.010] [PMID: ] - DOI - PubMed
    1. NCT00911664. Vitamin D supplementation and CD4 count in HIV-infected children. clinicaltrials.gov/ct2/show/NCT00911664 (first received 29 May 2009).
Kashif 2014 {published data only (unpublished sought but not used)}
    1. Kashif M, Rab ZZ, Ahmad J, Hasan A, Mirza S. To compare the effect of iron therapy alone versus combined iron therapy and vitamin D supplementation on cardiovascular functions in children with iron deficiency anemia by echocardiography: a randomized controlled trial. Annals of Pediatric Cardiology 2014;7(Suppl 4):S93. [Abstract #PA 70] [www.annalspc.com/showBackIssue.asp?issn=0974-2069;year=2014;volume=7;iss...
Kazemi 2010 {published data only (unpublished sought but not used)}
    1. Kazemi SAN, Bordbar M, Amirmoghaddami HR, Mousavinasab N. The effect of high dose vitamin D3 on the level of serum alkaline phosphatase, calcium, phosphor and vitamin D3 in children older than 3 years old who were receiving phenobarbital. Journal of Advances in Medical and Biomedical Research 2010;18(72):62-70. [www.sid.ir/en/Journal/ViewPaper.aspx?ID=256376]
Kerley 2017 {published data only (unpublished sought but not used)}
    1. Kerley CP, Elnazir B, Greally P, Coghlan D. Blunted serum 25(OH)D response to vitamin D3 supplementation in children with autism. Nutritional Neuroscience 2020;23(7):537-42. [DOI: 10.1080/1028415X.2018.1529342] [PMID: ] - DOI - PubMed
    1. Kerley CP, Power C, Gallagher L, Coghlan D. Lack of effect of vitamin D3 supplementation in autism: a 20-week, placebo-controlled RCT. Archives of Disease in Childhood 2017;102(11):1030-6. [DOI: 10.1136/archdischild-2017-312783] [PMID: ] - DOI - PubMed
    1. NCT02508922. Trial of vitamin D3 supplementation in paediatric autism [Vitamin D3 for autism spectrum disorder: a randomized, double-blind, placebo-controlled trial]. clinicaltrials.gov/ct2/show/NCT02508922 (first received 24 July 2015).
Lal 2018 {published data only (unpublished sought but not used)}
    1. Lal BB, Alam S, Khanna R, Rawat D. Weekly regimen of vitamin D supplementation is more efficacious than Stoss regimen for treatment of vitamin D deficiency in children with chronic liver diseases. European Journal of Pediatrics 2018;177(6):827-34. [DOI: 10.1007/s00431-018-3123-0] [PMID: ] - DOI - PubMed
    1. Lal BB, Alam S, Khanna R, Rawat D. Weekly regimen of vitamin D supplementation is more efficacious than Stoss regimen for treatment of vitamin D deficiency in children with non-cholestatic chronic liver diseases. Hepatology International 2018;12(Suppl 2):S615. [DOI: 10.1007/s12072-018-9852-3] [Abstract #LATEB-32] - DOI - PubMed
    1. Lal BB, Khanna R, Alam S, Rawat D. Weekly regimen of vitamin D supplementation is more effective than Stoss regimen for treatment of hypovitaminosis D in children with chronic liver disease. Journal of Clinical and Experimental Hepatology 2017;7(Suppl 2):S94-5. [DOI: 10.1016/j.jceh.2017.05.170] - DOI
Lara‐Corrales 2019 {published data only (unpublished sought but not used)}
    1. Lara-Corrales I, Gomez GR, De Los Rios CP, Pope E. Vitamin D in patients with atopic dermatitis: a randomized, double-blinded, placebo-controlled study preliminary analysis. Pediatric Dermatology 2013;30(5):638. [DOI: 10.1111/pde.12241] - DOI
    1. Lara-Corrales I, Huang CM, Parkin PC, Rubio-Gomez GA, Posso-De Los Rios, Maguire J, et al. Vitamin D level and supplementation in pediatric atopic dermatitis: a randomized controlled trial. Journal of Cutaneous Medicine and Surgery 2019;23(1):44-9. [DOI: 10.1177/1203475418805744] [PMID: ] - DOI - PubMed
Lee 2018 {published data only (unpublished sought but not used)}
    1. Lee MT, Kattan M, Fennoy I, Apradi SM, Miller RL, Cremers S, et al. Randomized phase 2 trial of monthly vitamin D to prevent respiratory complications in children with sickle cell disease. Blood Advances 2018;2(9):969-78. [DOI: 10.1182/bloodadvances.2017013979] [PMC5941998] [PMID: ] - DOI - PMC - PubMed
    1. NCT01443728. Vitamin D for sickle-cell respiratory complications. clinicaltrials.gov/ct2/show/NCT01443728 (first received 27 September 2011).
Loeb 2019 {published data only (unpublished sought but not used)}
    1. Loeb M, Dang AD, Thiem VD, Thanablan V, Wang B, Nguyen NB, et al. Effect of vitamin D supplementation to reduce respiratory infections in children and adolescents in Vietnam: a randomized controlled trial. Influenza and Other Respiratory Viruses 2019;13(2):176-83. [DOI: 10.1111/irv.12615] [PMC6379634] [PMID: ] - DOI - PMC - PubMed
    1. NCT01705314. A randomized trial of vitamin D to reduce respiratory infection [Effect of vitamin D3 supplementation to reduce respiratory infections in children and adolescents in Vietnam: a blinded, placebo-controlled randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT01705314 (first received 9 October 2012).
Mazahery 2019 {published data only (unpublished sought but not used)}
    1. ACTRN12615000144516. Omega-3, vitamin D and autism in children [Effect of vitamin D and omega-3 fatty acid supplements on behavioural measures in children with autism spectrum disorder (ASD): a randomised, double-blind, placebo-controlled trial]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366358 (first received 29 October 2014).
    1. Mazahery H, Conlon C, Beck KL, Kruger MC, Stonehouse W, Camargo CA Jr, et al. Vitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: a study protocol for a factorial randomised, double-blind, placebo-controlled trial. Trials 2016;17(1):295. [DOI: 10.1186/s13063-016-1428-8] [PMC4917935] [PMID: ] - DOI - PMC - PubMed
    1. Mazahery H, Conlon CA, Beck KL, Mugridge O, Kruger MC, Stonehouse W, et al. A randomised-controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of core symptoms of autism spectrum disorder in children. Journal of Autism and Developmental Disorders 2019;49(5):1778-94. [DOI: 10.1007/s10803-018-3860-y] [PMID: ] - DOI - PubMed
    1. Mazahery H, Conlon CA, Beck KL, Mugridge O, Kruger MC, Stonehouse W, et al. A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder. Journal of Steroid Biochemistry and Molecular Biology 2019;187:9-16. [DOI: 10.1016/j.jsbmb.2018.10.017] [PMID: ] - DOI - PubMed
Merrikhi 2018 {published data only (unpublished sought but not used)}
    1. IRCT2017052221968N2. Effectiveness of vitamin D supplement in prevention of recurrent urinary tract infections in children [Effectiveness of vitamin D supplement in prevention of urinary tract infections in children with recurrent urinary tract infection]. en.irct.ir/trial/19083 (first received 10 August 2017).
    1. Merrikhi A, Ziaei E, Shahsanai A, Kelishadi R, Maghami-Mehr A. Is vitamin D supplementation effective in prevention of recurrent urinary tract infections in the pediatrics? A randomized triple-masked controlled trial. Advanced Biomedical Research 2018;7:150. [DOI: 10.4103/abr.abr_149_18] [PMC6289001] [PMID: ] - DOI - PMC - PubMed
Morcos 1998 {published data only (unpublished sought but not used)}
    1. Morcos MM, Gabr AA, Samuel S, Kamel M, El Baz M, El Beshry M, et al. Vitamin D administration to tuberculous children and its value. Bollettino Chimico Farmaceutico 1998;137(5):157-64. [PMID: ] - PubMed
Mortensen 2016 {published data only (unpublished sought but not used)}
    1. Hauger H, Mølgaard C, Mortensen C, Ritz C, Frøkiær H, Smith TJ, et al. Winter cholecalciferol supplementation at 55°N has no effect on markers of cardiometabolic risk in healthy children aged 4-8 years. Journal of Nutrition 2018;148(8):1261-8. [DOI: 10.1093/jn/nxy080] [PMID: ] - DOI - PubMed
    1. Hauger H, Ritz C, Mortensen C, Mølgaard C, Metzdorff SB, Frøkiær H, et al. Winter cholecalciferol supplementation at 55°N has little effect on markers of innate immune defense in healthy children aged 4–8 years: a secondary analysis from a randomized controlled trial. European Journal of Nutrition 2019;58(4):1453-62. [DOI: 10.1007/s00394-018-1671-8] [PMID: ] - DOI - PubMed
    1. Mortensen C, Damsgaard CT, Hauger H, Ritz C, Lanham-New SA, Smith TJ, et al. Estimation of the dietary requirement for vitamin D in white children aged 4-8 y: a randomized, controlled, dose-response trial. American Journal of Clinical Nutrition 2016;104(5):1310-7. [DOI: 10.3945/ajcn.116.136697] [PMID: ] - DOI - PubMed
    1. Mortensen C, Mølgaard C, Hauger H, Kristensen M, Damsgaard CT. Winter vitamin D3 supplementation does not increase muscle strength, but modulates the IGF-axis in young children. European Journal of Nutrition 2019;58(3):1183-92. [DOI: 10.1007/s00394-018-1637-x] [PMID: ] - DOI - PubMed
    1. NCT02145195. The effect of vitamin D supplements on vitamin D status, cardiometabolic health and immune defense in Danish children (ODIN Junior) [Food-based solutions for optimal vitamin D nutrition and health through the life cycle (ODIN) Junior]. clinicaltrials.gov/ct2/show/NCT02145195 (first received 20 May 2014).
Muske 2018 {published data only (unpublished sought but not used)}
    1. CTRI/2015/04/005721. Comparison of two different vitamin D doses for bone strength protection in nephrotic syndrome [Comparison of two vitamin D dosing regimens for osteoprotection in children with new-onset and infrequently relapsing nephrotic syndrome treated with steroids: a randomized trial]. ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=11326&EncHid=&am... (first received 27 April 2015).
    1. Muske S, Krishnamurthy S, Kamalanathan SK, Rajappa M, Harichandrakumar KT, Sivamurukan P. Effect of two prophylactic bolus vitamin D dosing regimens (1000 IU/day vs 400 IU/day) on bone mineral content in new-onset and infrequently-relapsing nephrotic syndrome: a randomised clinical trial. Paediatrics and International Child Health 2018;38(1):23-33. [DOI: 10.1080/20469047.2017.1319528] [PMID: ] - DOI - PubMed
Nwosu 2014 {published data only (unpublished sought but not used)}
    1. Nwosu BU, Maranda L. The effects of vitamin D supplementation on hepatic dysfunction, vitamin D status, and glycemic control in children and adolescents with vitamin D deficiency and either type 1 or type 2 diabetes mellitus. PloS One 2014;9(6):e99646. [DOI: 10.1371/journal.pone.0099646] [PMC4053366] [PMID: ] - DOI - PMC - PubMed
Rahmati 2018 {published data only (unpublished sought but not used)}
    1. Rahmati MB, Nikbakht A, Ahmadi M. Evaluation of the effect of vitamin D on the length of hospital stay in children with gastroenteritis aged 3 months to 14 years admitted to the Pediatric Hospital of Bandar Abbas. Hormozgan Medical Journal 2018;22(3):e86323. [DOI: 10.5812/hmj.86323] - DOI
Saad 2018 {published data only}
    1. Beale DJ. Letter to the Editor: unreported statistics lead to unverifiable results in study of vitamin D supplementation in children with autism spectrum disorder—comment regarding Saad K, et al (2016). Journal of Child Psychology and Psychiatry 2018;59(1):e1. [DOI: 10.1111/jcpp.12776] [PMID: ] - DOI - PubMed
    1. Saad K, Abdel-Rahman A, Elserogy Y, Al-Atram A, El-Houfey A, Othman H, et al. Retraction: randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder. Journal of Child Psychology and Psychiatry 2019;60(6):711. [DOI: 10.1111/jcpp.13076] [PMID: ] - DOI - PubMed
    1. Saad K, Abdel-Rahman AA, Elserogy YM, Al-Atram AA, El-Houfey AA, Othman HA-K, et al. Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder. Journal of Child Psychology and Psychiatry 2018;59(1):20-9. Retraction in: Journal of Child Psychology and Psychiatry 2019;60(6):711. DOI: 10.1111/jcpp.13076; PubMed: 31087556. [DOI: 10.1111/jcpp.12652] [PMID: ] - DOI - PubMed
    1. Saad K. Response to letters: randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder—correction and additional information. Journal of Child Psychology and Psychiatry 2018;59(1):e3-e5. [DOI: 10.1111/jcpp.12788] [PMID: ] - DOI - PubMed
    1. Sonuga-Barke E. Letter to the author from Editor-in-Chief seeking clarifications. Journal of Child Psychology and Psychiatry 2018;59(1):e2-e3. [DOI: 10.1111/jcpp.12800] [PMID: ] - DOI - PubMed
Sharma 2017 {published data only (unpublished sought but not used)}
    1. CTRI/2014/07/004739. Role of vitamin D as an added therapy for type 1 diabetes mellitus patients [Role of oral cholecalciferol as an adjunctive therapy in type 1 diabetes mellitus: a randomized controlled trial]. www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=8907&EncHid=... (first received 15 July 2014).
    1. Sharma S, Biswal N, Bethou A, Rajappa M, Kumar S, Vinayagam V. Does vitamin D supplementation improve glycaemic control in children with type 1 diabetes mellitus? A randomized controlled trial. Journal of Clinical and Diagnostic Research 2017;11(9):SC15-7. [DOI: 10.7860/JCDR/2017/27321.10645] [PMC5713820] [PMID: ] - DOI - PMC - PubMed
Shroff 2012 {published data only (unpublished sought but not used)}
    1. Shroff R, Wan M, Gullett A, Ledermann S, Shute R, Knott C, et al. Ergocalciferol supplementation in children with CKD delays the onset of secondary hyperparathyroidism: a randomized trial. Clinical Journal of the American Society of Nephrology 2012;7(2):216-23. [DOI: 10.2215/CJN.04760511] [PMID: ] - DOI - PubMed
    1. Shroff R, Wan M, Gullett A, Ledermann S, Shute R, Knott C, et al. Ergocalciferol supplementation in children with CKD delays the onset of secondary hyperparathyroidism--a randomised, double-blinded placebo controlled study. Pediatric Nephrology 2011;26(9):1634. [DOI: 10.1007/s00467-011-1958-y] [Abstract #PS1-THU-506] - DOI - PubMed
Siafarikas 2009 {published data only (unpublished sought but not used)}
    1. Siafarikas A, Pascoe E, Banfiel S, Cherian S, Geddes J, Nemba K, et al. An evidence based approach to vitamin D deficiency in the child and adolescent refugee population of Western Australia (WA). Bone 2009;44(Suppl 1):S89-S90. [DOI: 10.1016/j.bone.2009.01.200] - DOI
Sidbury 2008 {published data only (unpublished sought but not used)}
    1. Sidbury R, Sullivan AF, Thadhani RI, Camargo CA Jr. Randomized controlled trial of vitamin D supplementation for winter-related atopic dermatitis in Boston: a pilot study. British Journal of Dermatology 2008;159(1):245-7. [DOI: 10.1111/j.1365-2133.2008.08601.x] [PMID: ] - DOI - PubMed
Simon 2016 {published data only}
    1. Pragathesh P. A Randomized Clinical Trial Comparing the Effects of Three Different Cholecalciferol Supplementation Protocols on Serum 25 Hydroxy Vitamin D Level in Asymptomatic Vitamin D Deficient Children [MD Pediatrics thesis]. Chennai (TN): Christian Medical College Vellore, 2013.
    1. Simon A, Pragathesh P, Priyambada L. An RCT comparing the effect of three different vitamin D supplementation regimens on Se 25 OH Vit D in asymptomatic vit D deficient children. Hormone Research in Paediatrics 2016;86(Suppl 1):176-7. [DOI: 10.1159/000449142] [Abstract #P1-P134] - DOI
Singh 2018b {published data only (unpublished sought but not used)}
    1. CTRI/2016/10/007405. Comparison of the efficacy of two dosing regimens of vitamin D for bone protection in children with difficult nephrotic syndrome [Comparison of the efficacy of two dosing regimens of vitamin D supplementation for osteoprotection in children with difficult nephrotic syndrome: an open-label randomized clinical trial]. ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=12607&EncHid=&am... (first received 25 October 2016).
    1. Singh DN, Krishnamurthy S, Kamalanathan SK, Harichandrakumar KT, Sivamurukan P. Three-monthly bolus vitamin D supplements (1000 vs 400 IU/day) for prevention of bone loss in children with difficult-to-treat nephrotic syndrome: a randomised clinical trial. Paediatrics and International Child Health 2018;38(4):251-60. [DOI: 10.1080/20469047.2018.1505589] [PMID: ] - DOI - PubMed
Suryanto 2018 {published data only (unpublished sought but not used)}
    1. Suryanto T, Tjahjono HA, Widjajanto E. Levels of 25(OH)D3, IL-2, and C-peptide in children with type 1 diabetes mellitus (T1DM) receiving vitamin D3 supplementation. Journal of Tropical Life Science 2018;8(1):28-36. [DOI: 10.11594/jtls.08.01.06] - DOI
Swangtrakul 2020 {published data only (unpublished sought but not used)}
    1. Swangtrakul N, Manuyakorn W, Mahachoklertwattana P, Kiewngam P, Sasisakulporn C. Effect of vitamin D on lung function assessed by forced oscillation technique in asthmatic children with vitamin D deficiency: a randomized double-blind placebo-controlled trial. Asian Pacific Journal of Allergy and Immunology 2020 Dec 14 [Epub ahead of print]. [DOI: 10.12932/AP-010519-0553] [PMID: ] - DOI - PubMed
    1. TCTR20170422001. A randomized double-blind placebo controlled trial of vitamin D supplementation in asthmatic children. www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&amp... (first received 20 April 2017).
Talaat 2016 {published data only (unpublished sought but not used)}
    1. Talaat IM, Kamal NM, Alghamdi HA, Alharthi AA, Alsharani MA. A randomized clinical trial comparing 3 different replacement regimens of vitamin D in clinically asymptomatic pediatrics and adolescents with vitamin D insufficiency. Italian Journal of Pediatrics 2016;42(1):106. [DOI: 10.1186/s13052-016-0314-z] [PMC5142392 ] [PMID: ] - DOI - PMC - PubMed
Tannous 2018 {published data only (unpublished sought but not used)}
    1. ACTRN12609000874213. This is a randomised study to assess the safety and efficacy of a high dose vitamin D supplement compared to the standard vitamin D therapy in children [A study to assess the safety and efficacy of Stoss therapy (high dose vitamin D supplement) compared to standard daily therapy in children diagnosed with simple vitamin D deficiency]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=320672 (first received 10 October 2009).
    1. Tannous P, Munns C. A randomized cohort study comparing the safety and effectiveness of high dose vitamin D to standard daily vitamin D therapy in children with vitamin D deficiency. Pediatrics & Therapeutics 2018;8(3):72. [10.4172/2161-0665-C3-058]
Udompataikul 2015 {published data only (unpublished sought but not used)}
    1. NCT02058186. Effect of oral vitamin D supplement on atopic dermatitis; a clinical trial with Staphylococcus aureus colonization determination. clinicaltrials.gov/ct2/show/NCT02058186 (first received 6 February 2014).
    1. Udompataikul M, Huajai S, Chalermchai T, Taweechotipatr M, Kamanamool N. The effects of oral vitamin D supplement on atopic dermatitis: a clinical trial with Staphylococcus aureus colonization determination. Journal of the Medical Association of Thailand 2015;98 Suppl 9:S23-30. [PMID: ] - PubMed
Wadia 2018 {published data only (unpublished sought but not used)}
    1. ACTRN12611001177943. Comparison of depot versus daily vitamin D3 for supplementation in refugees in Western Australia [Randomized controlled trial comparing depot and daily vitamin D3 therapy in 0-16 year old refugees in Western Australia looking at the change in 25(OH)D levels as the primary outcome]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347634 (first received 10 November 2011).
    1. Wadia U, Cherian S, Thambiran A, Burgner D, Siafarikas A. Randomised controlled trial comparing daily versus depot vitamin D3 for the treatment of vitamin D deficiency in 0-16 year old refugees in Western Australia. Bone 2011;48(Suppl 2):S247. [DOI: 10.1016/j.bone.2011.03.599] [Abstract #PP468-T] - DOI
    1. Wadia U, Soon W, Chivers P, Thambiran A, Burgner D, Cherian S, et al. Randomised controlled trial comparing daily versus depot vitamin D3 therapy in 0-16-year-old newly settled refugees in western Australia over a period of 40 weeks. Nutrients 2018;10(3):348. [DOI: 10.3390/nu10030348] [PMC5872766] [PMID: ] - DOI - PMC - PubMed
Zulkarnain 2019 {published data only (unpublished sought but not used)}
    1. Zulkarnain I, Rahmawati YW, Setyaningrum T, Citrashanty I, Aditama L, Avanti C. Vitamin D3 supplementation reduced Staphylococcus aureus colonization in the skin of pediatric patients with atopic dermatitis. European Journal of Pediatric Dermatology 2019;29(3):143-9. [DOI: 10.26326/2281-9649.29.3.2001] - DOI

References to studies awaiting assessment

Bantz 2015 {published data only (unpublished sought but not used)}
    1. Bantz SK, Dy T, Herzog R. Vitamin D deficiency in a young, atopic pediatric population. Journal of Allergy and Clinical Immunology 2015;135(2 Suppl):AB148. [DOI: 10.1016/j.jaci.2014.12.1421] [Abstract #481] - DOI
Behnamfar 2011 {published data only (unpublished sought but not used)}
    1. Behnamfar Z, Mehrdad S, Zahra B. Effect of maintenance dose (30000 unit per month) 25-hydroxyvitamin D on upper respiratory tract infection in children of day care center. European Journal of Medical Research 2011;16(Suppl 1):49. [DOI: 10.1186/2047-783X-16-S1-1] [Abstract #641] - DOI
CTRI/2014/04/004574 {published data only (unpublished sought but not used)}
    1. CTRI/2014/04/004574. A clinical trial to compare the effects of iron therapy alone versus combined iron therapy and vitamin D supplementation on cardiovascular functions in children with iron deficiency anemia [Comparison of effect of iron therapy alone versus combined iron therapy and vitamin Dsupplementation on cardiovascular functions in children with iron deficiency anemia]. www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2014/04/004574 (first received 28 April 2014).
CTRI/2015/08/006084 {published data only (unpublished sought but not used)}
    1. CTRI/2015/08/006084. Effect of two different regimens of vitamin D supplementation on serum vitamin D levels in children [A study to compare the effect of two different regimens of vitamin D supplementation on serum vitamin D levels in children: a randomized controlled trial]. www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2015/08/006084 (first received 10 August 2015).
CTRI/2019/02/017374 {published data only (unpublished sought but not used)}
    1. CTRI/2019/02/017374. Comparison of the efficacy of two doses of vitamin D supplementation to prevent Vitamin D deficiency in healthy term breastfed infants [Efficacy of 800 IU versus 400 IU per day of oral vitamin D3 supplementation on vitamin D sufficiency in healthy, breastfed infants: a randomized controlled trial]. www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2019/02/017374 (first received 1 February 2019).
Hagag 2020 {published data only (unpublished sought but not used)}
    1. Hagag AA, El Frargy MS, Houdeeb HA. Therapeutic value of vitamin D as an adjuvant therapy in neonates with sepsis. Infectious Disorders. Drug Targets 2020;20(4):440-7. [DOI: 10.2174/1871526519666190626141859] [PMID: ] - DOI - PubMed
IRCT20111206008307N {published data only (unpublished sought but not used)}
    1. IRCT20111206008307N. Evaluation of effect of different type of vitamin D on biochemical markers of osteopenia of prematurity [Comparison of calcitriol and cholecalciferol on biochemical markers of metabolic bone disease in very low birth weight infants]. en.irct.ir/trial/30580 (first received 10 June 2018).
IRCT20131013014994N5 {published data only (unpublished sought but not used)}
    1. IRCT20131013014994N5. Effect of vitamin D on autism spectrum disorders [Effect of vitamin D supplementation on core symptoms and serum biomarkers (serotonin and IL-6) in children with autism spectrum disorders]. en.irct.ir/trial/14421 (first received 18 April 2018).
IRCT2014053117843N3 {published data only (unpublished sought but not used)}
    1. IRCT2014053117843N3. Vitamin D supplementation and its effect on markers of oxidative stress and antioxidant in asthmatic children [Effect of oral vitamin D supplementation on serum markers of oxidative stress and antioxidant in asthmatic children and its comparison with control group]. en.irct.ir/trial/16324?revision=16324 (first received 4 August 2014).
NCT01229189 {published data only (unpublished sought but not used)}
    1. NCT01229189. Evaluation of the effectiveness of vitamin D supplementation to pregnant women and their infants in Pakistan. clinicaltrials.gov/ct2/show/NCT01229189 (first received 26 October 2010).
NCT01419821 {published data only (unpublished sought but not used)}
    1. NCT01419821. Vitamin D and its affect on growth rates and bone mineral density until age 5 (VitD) [Supplemental vitamin D administered to one year old vitamin D deficient infants until age 3 and its affect on growth rates and bone mineral density until age 5]. clinicaltrials.gov/ct2/show/NCT01419821 (first received 17 August 2011).
NCT01656070 {published data only (unpublished sought but not used)}
    1. NCT01656070. Vitamin D supplementation in HIV-infected youth [Vitamin D status and T cell phenotype in HIV-infected youth supplemented with cholecalciferol: a randomized clinical trial]. clinicaltrials.gov/ct2/show/NCT01656070 (first received 31 July 2012).
NCT01724190 {published data only (unpublished sought but not used)}
    1. NCT01724190. Effect of vitamin D on the honeymoon period in children and adolescents with type 1 diabetes [Effect of Vitamin D supplementation on rate of partial clinical remission in children and adolescents with type 1 diabetes]. clinicaltrials.gov/ct2/show/NCT01724190 (first received 7 November 2012).
NCT02054182 {published data only (unpublished sought but not used)}
    1. NCT02054182. Effect of vitamin D supplementation in young South African children hospitalized with acute lower respiratory infection [Effect of vitamin D supplementation in young children with acute lower respiratory tract infection at Dr George Mukhari Academic Hospital, Pretoria, South Africa]. clinicaltrials.gov/ct2/show/NCT02054182 (first received 18 January 2014).
NCT02185196 {published data only (unpublished sought but not used)}
    1. NCT02185196. Vitamin-D supplementation: impact on severe pneumonia among under-five children (Vitamin-D) [Vitamin-D supplementation: impact on severe pneumonia among under-five children]. clinicaltrials.gov/ct2/show/NCT02185196 (first received 22 June 2014).
NCT02186028 {published data only (unpublished sought but not used)}
    1. NCT02186028. Effect of oral daily supplementation with 400 IU Vs 200 IU of vitamin D in term healthy neonates [Effect of oral daily supplementation with 400 IU Vs 200 IU of vitamin D In term healthy newborns: a randomised control trial]. clinicaltrials.gov/ct2/show/NCT02186028 (first received 7 July 2014).
NCT02936895 {published data only (unpublished sought but not used)}
    1. NCT02936895. Vitamin D supplementation and respiratory index of severity in children (RISC) in pneumonia [The effects of vitamin D supplementation in Respiratory Index of Severity in Children (RISC) of hospitalized patients with community-acquired pneumonia]. clinicaltrials.gov/ct2/show/NCT02936895 (first received 12 October 2016).
NCT03176849 {published data only (unpublished sought but not used)}
    1. NCT03176849. A randomized phase IV control trial of single high dose oral vitamin D3 in pediatric patients undergoing HSCT [A randomized phase IV control trial of single high dose oral vitamin D3 (Stoss therapy) in pediatric patients undergoing HSCT to prevent vitamin D deficiency and insufficiency during transplant]. clinicaltrials.gov/ct2/show/NCT03176849 (first received 26 May 2017).
NCT03544671 {published data only (unpublished sought but not used)}
    1. NCT03544671. Effect of vitamin D3 supplementation in children from 12 to 30 months of age [Effect of vitamin D3 supplementation over 25-hydroxivitamin D (25-OH-D) status in children from 12-30 months of age: randomized clinical trial]. clinicaltrials.gov/ct2/show/NCT03544671 (first received 17 May 2018).
NTR477 {published data only (unpublished sought but not used)}
    1. ISRCTN23173889. Molecular determinants of bone mineral density (BMD) in children with acute lymphoblastic leukemia (ALL) and the role of intervention by physical activities and calcium and vitamin D supplements as a preventive strategy. www.isrctn.com/ISRCTN23173889 (first received 27 January 2006). [DOI: 10.1186/ISRCTN23173889] - DOI
    1. NTR477. Molecular determinants of bone mineral density in children with acute lymphoblastic leukemia and the role of intervention by physical activities and calcium and vitamin D supplement as a preventive strategy [Molecular determinants of bone mineral density in children with acute lymphoblastic leukemia (ALL) and the role of intervention by physical activities and calcium and vitamin D supplement as a preventive strategy]. www.who.int/trialsearch/Trial2.aspx?TrialID=NTR477 (first received 14 September 2005).
Özkan 2000 {published data only (unpublished sought but not used)}
    1. Özkan B, Büyükavci M, Energin M, Dirican ME, Alp H, Akdağ R. Nutritional rickets: comparison of three different therapeutic approaches (300.000 U p.o., 300.000 U i.m. and 600.000 U p.o.) [Nütrisyonel riketsde farklı tedavi șekillerinin (300.000 U oral, 300.000 U intramusküler ve 600.000 U oral vitamin D) karșılaștırılması]. Çocuk Sağliğı ve Hastalıkları Dergisi 2000;43(1):30-5. [Record #20001412893] [www.cabdirect.org/cabdirect/abstract/20001412893]

References to ongoing studies

ACTRN12614000334606/NCT02112734 {published data only}
    1. Allen KJ, Panjari M, Koplin JJ, Ponsonby A-L, Vuillermin P, Gurrin LC, et al. VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health. BMJ Open 2015;5(12):e009377. [DOI: 10.1136/bmjopen-2015-009377] - DOI - PMC - PubMed
    1. ANZCTR12614000334606. Can vitamin D supplementation in infants prevent food allergy in the first year of life? The VITALITY trial [A placebo-controlled, randomised trial of vitamin D supplementation for infants in their first year of life, to prevent the development of food allergy by age 12 months. The VITALITY Trial]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000334606 (first received 20 March 2014).
    1. NCT02112734. Can vitamin D supplementation in infants prevent food allergy in the first year of life? The VITALITY trial (VITALITY) [Can vitamin D supplementation in infants prevent food allergy in the first year of life? The VITALITY trial]. clinicaltrials.gov/ct2/show/NCT02112734 (first received 10 April 2014).
ACTRN12616000659404 {published data only}
    1. ACTRN12616000659404. PREVARID—PREVention of Acute Respiratory Infections with Vitamin D [Does vitamin D supplementation prevent acute respiratory infection health care visits among children under 2 years old? A randomised controlled trial]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369897 (first received 25 January 2016).
CTRI/2013/04/003566 {published data only}
    1. CTRI/2013/04/003566. Vitamin D supplementation and responses to vaccines in infants [Vitamin D supplementation to improve immune responses to vaccines administered in early infancy – the Nutrivac-D trial]. www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=6170&EncHid=... (first received 17 April 2013).
CTRI/2015/08/006132 {published data only}
    1. CTRI/2015/08/006132. A clinical trial to evaluate the need for routine vitamin D supplementation till six months age in full term babies who are being exclusively breastfed [Vitamin D oral supplementation evaluation in full-term, exclusively breastfed infants—a randomized controlled study]. www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=10328&EncHid... (first received 21 August 2015).
CTRI/2016/12/007519 {published data only}
    1. CTRI/2016/12/007519. Vitamin D levels in preterm babies [Vitamin D levels of the term small-for-date newborns at birth and at 3 month of age after vitamin D supplementation with 2 different doses 400 IU v/s 800 IU—a randomized control trial]. www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2016/12/007519 (first received 1 December 2016).
CTRI/2017/10/010274 {published data only}
    1. CTRI/2017/10/010274. Role of vitamin D3 intake and decrease in respiratory infections [Randomised trial of two different doses of vitamin D supplementation and risk of acute respiratory infection in children in Rural Kolar, Karnataka]. www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2017/10/010274 (first received 31 October 2017).
CTRI/2017/11/010385 {published data only (unpublished sought but not used)}
    1. CTRI/2017/11/010385. Dose of vitamin D in children with chronic kidney disease [Optimal dose of cholecalciferol supplementation in Indian children with chronic kidney disease—a randomised control trial]. ctri.nic.in/Clinicaltrials/showallp.php?mid1=13495&EncHid=&userN... (first received 6 November 2017).
    1. Iyengar AA, Kamath N, Hamsa V, Uthup S, Sharma J, Singhal J, et al. Determining the optimal dose of cholecalciferol supplementation in children with chronic kidney disease (C3 trial): design of an open-label multicenter randomized controlled trial. Asian Journal of Pediatric Nephrology 2018;1(2):67-73. [DOI: 10.4103/ajpn.Ajpn_34_18] - DOI
    1. Kamath N, Iyengar A, Reddy HV, Uthup S, Sharma J, Singhal J, et al. Determining the optimal dose of cholecalciferol supplementation in children with chronic kidney disease (C3 trial)—an open label multicentre randomized controlled trial. Kidney International Reports 2019;4(Suppl 7):S120-1. [DOI: 10.1016/j.ekir.2019.05.308] [Abstract #Sat-271] - DOI
CTRI/2017/12/010827 {published data only}
    1. CTRI/2017/12/010827. Effect of vitamin D supplementation on post operative surgical outcomes in children with cyanotic congenital heart disease undergoing open heart surgery: a randomised controlled trial [Effect of vitamin D supplementation on outcome in children undergoing open heart surgery: a randomised controlled trial]. www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2017/12/010827 (first received 11 December 2017).
CTRI/2018/04/013300 {published data only}
    1. CTRI/2018/04/013300. A clinical trial to compare three different regimes for treatment of nutritional rickets in children [To evaluate the efficacy of daily vitamin D therapy versus Stoss therapy in nutritional rickets inIndian children: a randomized controlled trial]. www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2018/04/013300 (first received 16 April 2018).
CTRI/2018/12/016760 {published data only}
    1. CTRI/2018/12/016760. Daily versus bolus oral vitamin D3 for treatment of rickets in children [Daily versus depot oral vitamin D3 for treating nutritional rickets]. www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2018/12/016760 (first received 21 December 2018).
Galdo 2018 {published data only (unpublished sought but not used)}
    1. EUCTR 2013-005326-38. Digitoxin to improve outcomes in patients with advanced systolic chronic heart failure [A multicenter, randomized, double-blind, placebo-controlled study to demonstrate that digitoxin reduces a composite of overall mortality and hospitalization for worsening heart failure in patients with chronic heart failure and reduced ejection fraction]. www.clinicaltrialsregister.eu/ctr-search/trial/2013-005326-38/DE (first received 18 November 2014).
    1. Galdo AM, De Aguileta AL, Mercader PT, Estela AC, Marcos MIM, Murua JK, et al. Effect of supplementation with vitamin D on acute bronchitis prevention during the first year of life. European Respiratory Journal 2018;52(Suppl 62):PA4593. [DOI: 10.1183/13993003.congress-2018.PA4593] [Abstract #PA4593] - DOI
    1. NCT01875757. Effect of supplementation with vitamin D on the acute bronchitis prevention during the first year of life (VitDBR2012) [Effect of supplementation with vitamin D on the acute bronchitis prevention during the first year of life]. clinicaltrials.gov/ct2/show/NCT01875757 (first received 10 June 2013).
IRCT20171030037093N4 {published data only (unpublished sought but not used)}
    1. IRCT20171030037093N4. Effect of vitamin D supplement on the level of serum vitamin D in preterm neonates [Comparing the effect of different doses of vitamin D supplement on the level of serum 25(OH) vitamin D and bone metabolism related factors in preterm neonates]. en.irct.ir/trial/37624 (first received 3 March 2019).
Kishore 2019 {published data only (unpublished sought but not used)}
    1. Kishore SS, Gadiraju M. Study of daily vitamin D supplementation in preterm infants: a randomized trial. Journal of Pediatric Gastroenterology and Nutrition 2019;68(Suppl 1):1167. [Abstract #N-P-121]
NCT01050387 {published data only (unpublished sought but not used)}
    1. NCT01050387. Effects of vitamin D dose and genotype of the binding protein in infants and children (VitaD) [A randomized, controlled trial of vitamin D supplementation in infants and children: effects of vitamin D dose and genotype of the binding protein]. clinicaltrials.gov/ct2/show/NCT01050387 (first received 13 January 2010).
    1. Simpson C, Zhang J, Vanderschueren D, Fu L, Pennestri T, Bouillon R, et al. A randomized trial of vitamin D supplementation in healthy inner-city children. Journal of Bone and Mineral Research 2018;33:402. [DOI: 10.1002/jbmr.3621] [MON-0856] - DOI
NCT01363167 {published data only (unpublished sought but not used)}
    1. NCT01363167. Identifying vitamin D deficiency in very low birth weight infant (VLBW) infants part 2 [Identifying vit D deficiency in VLBW infants part 2]. clinicaltrials.gov/ct2/show/NCT01363167 (first received 18 April 2011).
    1. Taylor S, Wagner C, Finch C, Ebeling M, Hollis B. Very low birth weight infant vitamin D supplementation: double-blind, randomized clinical efficacy trial. FASEB Journal 2014;28(Suppl 1):828.13. [DOI: 10.1096/fasebj.28.1_supplement.828.13] - DOI
    1. Taylor SN, Wagner CL, Finch C, Ebeling M, Hollis HW. Very low birth weight infant mineral and bone health outcomes with vitamin D supplementation: double-blind, randomized clinical efficacy trial. In: Pediatric Academic Societies and Asian Society for Pediatric Research Joint Meeting; 2014 May 3-6; Vancouver (BC). 2014. [Abstract #432] [bluetoadpublishing.co.uk/publication/?i=203855&p=193&pp=1&vi...
NCT01698840 {published data only}
    1. NCT01698840. Effect of vitamin D in diets of preterm infants [An evaluation of the effects of two levels of vitamin D in infants fed preterm or transitional formula on serum 25-hydroxyvitamin D and bone status in preterm infants: a double-blind, randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT01698840 (first received 24 September 2012).
NCT01838447 {published and unpublished data}
    1. McNally D, O'Hearn K, Lougheed J, Fergusson D, Maharajh G, Weiler H, et al. Prevention of post-cardiac surgery vitamin D deficiency in children with congenital heart disease: results of a pilot dose evaluation randomized controlled trial. Pediatric Critical Care Medicine 2018;19(Suppl 6):46. [DOI: 10.1097/01.pcc.0000537451.52429.d6] [Abstract #PD-049] - DOI - PMC - PubMed
    1. McNally JD, O'Hearn K, Lawson ML, Maharajh G, Geier P, Wiler H, et al. Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial. Trials 2015;16:402. [DOI: 10.1186/s13063-015-0922-8] [PMC4564959] [PMID: ] - DOI - PMC - PubMed
    1. NCT01838447. Prevention of vitamin D deficiency following pediatric CHD surgery: a phase II dose evaluation randomized controlled trial comparing usual care with a high dose pre-operative supplementation regimen based on the Institute of Medicine daily upper tolerable Intake level (HICCUPS 2) [Prevention of post-cardiac surgery vitamin D deficiency in children with congenital heart disease: a pilot dose evaluation randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT01838447 (first received 11 April 2013).
NCT01996423 {published data only (unpublished sought but not used)}
    1. Borzutzky A, Cifuentes L, Silva-Valenzuela S, Vera-Kellet C, Iturriaga C, Perez-Mateluna G, et al. Effect of vitamin D supplementation on the severity of atopic dermatitis in children: the VIDATOPIC randomized controlled trial. In: Takaoka R , editors(s). ISAD 2016: 9th Georg Rajka International Symposium on Atopic Dermatitis; 2016 May 19-21; São Paulo (BR). Sao Paulo (BR): ISAD, 2016:70-1. [Abstract #PT45] [www.isadsociety.org/wp-content/uploads/ISAD-2016_program.pdf?v=2]
    1. Cristi F, Perez-Mateluna G, Vera-Kellet C, Silva-Valenzuela S, Iturriaga C, Hoyos-Bachiloglu R, et al. Vitamin D modulates the allergic phenotype of dendritic cells in children with atopic dermatitis. Experimental Dermatology 2019;28(3):308-11. [DOI: 10.1111/exd.13873] [PMID: ] - DOI - PubMed
    1. NCT01996423. Impact of vitamin D supplementation on severity of pediatric atopic dermatitis (VIDATOPIC) [Impact of vitamin D supplementation on clinical severity and immunologic tolerance of pediatric atopic dermatitis]. clinicaltrials.gov/ct2/show/study/NCT01996423 (first received 11 November 2013).
NCT02046577 {published data only (unpublished sought but not used)}
    1. Loureiro C, Brinkmann K, Campos L, Vizcaya C, Leroy C, Arancibia M, et al. Randomized study of vitamin D supplementation for the prevention of acute respiratory infections Aris of Chile in preschools. Hormone Research in Paediatrics 2018;90(Suppl 2):31-2. [DOI: 10.1177/1203475418805744] - DOI
    1. NCT02046577. Study of vitamin D for the prevention of acute respiratory infections in children [A randomized, double-blind, controlled trial of vitamin D for the prevention of acute respiratory infections in children aged 18 to 36 months in Santiago, Coyhaique and Punta Arenas, Chile]. clinicaltrials.gov/show/NCT02046577 (first received 23 January 2014).
NCT02404623 {published and unpublished data}
    1. Golan Tripto I, Bistritzer J, Loewenthal N, Dizitzer Y, Goldbart A. The effect of vitamin D administration on vitamin D status and respiratory morbidity in premature infants. Pediatric Pulmonology 2019;54(Suppl 1):S81. [DOI: 10.1002/ppul.24373] [Abstract #A-22] - DOI - PubMed
    1. NCT02404623. The effect of vitamin D administration to premature infants on vitamin D status and respiratory morbidity [The effect of vitamin D administration to premature infants on vitamin D status and respiratory morbidity during the first year of life]. clinicaltrials.gov/ct2/show/NCT02404623 (first received 18 March 2015).
NCT02452762 {published data only (unpublished sought but not used)}
    1. EUCTR 2016-002459-38. Rapid normalization of vitamin D in critically ill children [Rapid normalization of vitamin D in critically ill children: a phase II dose evaluation randomized controlled trial (VITdAL-PICU pilot)]. www.clinicaltrialsregister.eu/ctr-search/trial/2016-002459-38/AT (first received 19 January 2017).
    1. McNally D, Amrein K, O'Hearn K, Fergusson D, Geier P, Henderson M, et al. Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study). Pilot Feasibility Studies 2017;3(70):1-13. [DOI: 10.1186/s40814-017-0214-z] [PMC5721544] [PMID: ] - DOI - PMC - PubMed
    1. NCT02452762. Rapid normalization of vitamin D in critically Ill children: a phase II dose evaluation randomized controlled trial (VITdAL-PICU) [Rapid normalization of vitamin D in critically Ill children: a phase II dose evaluation randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT02452762 (first received 15 May 2015).
NCT02563015 {published data only (unpublished sought but not used)}
    1. NCT02563015. Can correction of low vitamin D status in infancy program for a leaner body composition? [Novel functional outcomes of vitamin D in infancy; can correction of low vitamin D status program for a leaner body composition phenotype?]. clinicaltrials.gov/ct2/show/NCT02563015 (first received 28 September 2015).
NCT02975492 {published data only}
    1. EUCTR 2016-001807-22-FR. Modalities of vitamin D supplementation and the risk of hypercalcemia in children aged 2 to 6 years. www.clinicaltrialsregister.eu/ctr-search/trial/2016-001807-22/FR (first received 20 July 2016).
    1. NCT02975492. Assessing the impact of a mode of vitamin D supplementation (sequential dose vs daily dose) on the incidence of hypercalciuria in children aged from 2 to 6 years (DonneDVit) [Evaluation de l'Impact d'un mode de supplémentation en vitamine D (dose séquentielle vs dose quotidienne) sur l'Incidence de l'hypercalciurie chez des enfants des départements du gard et de l'hérault agés de 2 à 6 ans. Etude contrôlée randomisée en 2 groupes parallèles]. clinicaltrials.gov/ct2/show/NCT02975492 (first received 7 November 2016).
NCT03087149 {published data only (unpublished sought but not used)}
    1. Kołodziejczyk A, Borszewska-Kornacka MK, Seliga-Siwecka J. MOnitored supplementation of VItamin D in preterm infants (MOSVID trial): study protocol for a randomised controlled trial. Trials 2017;18(1):424. [DOI: 10.1186/s13063-017-2141-y] [PMC5594536] [PMID: ] - DOI - PMC - PubMed
    1. NCT03087149. Monitored vs standard supplementation of vitamin D in preterm infants (MOSVID) [Supplementation of vitamin D in preterm infants—monitored therapy vs standard therapy. A randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT03087149?id=NCT03087149 (first received 15 March 2017). [NCT03087149]
NCT03365687 {published data only}
    1. Jensen ME, Ducharme FM, Alos N, Mailhot G, Mâsse B, White JH, et al. Vitamin D in the prevention of exacerbations of asthma in preschoolers (DIVA): protocol for a multicentre randomised placebo-controlled triple-blind trial. BMJ Open 2019;9(12):e033075. [DOI: 10.1136/bmjopen-2019-033075] [PMC6955525] [PMID: ] - DOI - PMC - PubMed
    1. NCT03365687. Vitamin D In the prevention of viral-induced asthma in preschoolers (DIVA) [Vitamin D In the prevention of viral-induced asthma in preschoolers: a randomized controlled multicenter trial (DIVA)]. clinicaltrials.gov/ct2/show/NCT03365687 (first received 3 December 2017).
NCT03536845 {published data only}
    1. Khalifah RA, Hudairi A, Homyani DA, Hamad MH, Bashiri FA. Vitamin D supplementation to prevent vitamin D deficiency for children with epilepsy: randomized pragmatic trial protocol. Medicine 2018;97(40):e12734. [DOI: 10.1097/MD.0000000000012734] [PMC6200520] [PMID: ] - DOI - PMC - PubMed
    1. NCT03536845. Vitamin D supplementation to prevent vitamin D deficiency for children with epilepsy [Vitamin D supplementation to prevent vitamin D deficiency for children with epilepsy: a randomized controlled clinical trial]. clinicaltrials.gov/ct2/show/NCT03536845 (first received 14 May 2018).
NCT03742310 {published data only}
    1. NCT03742310. The relationship between VDR gene polymorphism and children's physical and intellectual development (RVDRGPCPID) [Multi-center clinical study on the relationship between vitamin D receptor gene polymorphism and children's physical and intellectual development]. clinicaltrials.gov/ct2/show/NCT03742310 (first received 12 November 2018).
NCT03742505 {published data only}
    1. NCT03742505. Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS) [Rapid normalization of vitamin D deficiency in PICU: a multi-centre phase III double-blind randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT03742505 (first received 12 November 2018).
NCT03871322 {published data only}
    1. NCT03871322. The vitamin K2 and D3 intervention trial in children and adolescents with the low-energy fractures [Rationale and design of the vitamin K2 and vitamin D3 intervention trial in children and adolescents with the low-energy bone fractures]. clinicaltrials.gov/ct2/show/NCT03871322 (first received 7 March 2019).
NCT03999580 {published data only}
    1. NCT03999580. The vitamin D in pediatric Crohn's disease (ViDiPeC-2) (ViDiPeC-2) [A pragmatic randomized controlled trial on high dose vitamin D to prevent relapses of Crohn's disease in children]. clinicaltrials.gov/ct2/show/NCT03999580 (first received 24 June 2019).
RBR‐4r6p5v {published data only (unpublished sought but not used)}
    1. RBR-4r6p5v. Effect of physical exercise and nutritional programs on the health status of schoolchildren aged 4 to 11 years old from Santo Antônio de Goiás [Efeito de programas de exercício físico e nutricional sobre o estado de saúde deescolares de 4 a 11 anos de Santo Antôniode Goiás] [Metabolic syndrome: metabolic, oxidative and inflammatory responses of physical exercise and nutritional programs in schoolchildren aged 4 to 11 years old from Santo Antônio de Goiás [Síndrome metabólica: respostas metabólicas, oxidativas e inflamatórias de programas de exercício físico e nutricional em escolares de 4 a 11 anos de Santo Antônio de Goiás]]. www.ensaiosclinicos.gov.br/rg/RBR-4r6p5v/ (first received 23 May 2018). [UTN #U1111-1214-5845]
UMIN000034864 {published data only}
    1. UMIN000034864. Prevention of allergic march by vitamin D supplementation during infancy. upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037789 (first received 12 November 2018).
Yani 2018 {published data only (unpublished sought but not used)}
    1. Yani FF, Amelin F, Hamdi, Erisma R, Basir D, Lusita L, et al. Vitamin D level & tuberculin conversion among under five children with TB contact history after vitamin D supplementation. In: Asia Pacific Congress of Pediatrics 2018; 2018 Aug 27-29; Bali (ID). 2018. [Abstract #APCP406]
    1. Yani FF, Lipoeto NI, Supriyatno B, Darwin E. In: Vitamin D supplementation and tuberculin skin test conversion among healthy under-five children with tuberculosis contact. 17th International Congress of Pediatric Pulmonology; 2018 Jun 21-24; Toledo (ES). 2018. [Abstract #M125]

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