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Meta-Analysis
. 2020 Dec 11;12(12):CD013046.
doi: 10.1002/14651858.CD013046.pub2.

Vitamin D supplementation for term breastfed infants to prevent vitamin D deficiency and improve bone health

May Loong Tan  1 , Steven A Abrams  2 , David A Osborn  3
Affiliations
Meta-Analysis

Vitamin D supplementation for term breastfed infants to prevent vitamin D deficiency and improve bone health

May Loong Tan et al. Cochrane Database Syst Rev. .

Abstract

Background: Vitamin D deficiency is common worldwide, contributing to nutritional rickets and osteomalacia which have a major impact on health, growth, and development of infants, children and adolescents. Vitamin D levels are low in breast milk and exclusively breastfed infants are at risk of vitamin D insufficiency or deficiency.

Objectives: To determine the effect of vitamin D supplementation given to infants, or lactating mothers, on vitamin D deficiency, bone density and growth in healthy term breastfed infants.

Search methods: We used the standard search strategy of Cochrane Neonatal to 29 May 2020 supplemented by searches of clinical trials databases, conference proceedings, and citations.

Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs in breastfeeding mother-infant pairs comparing vitamin D supplementation given to infants or lactating mothers compared to placebo or no intervention, or sunlight, or that compare vitamin D supplementation of infants to supplementation of mothers.

Data collection and analysis: Two review authors assessed trial eligibility and risk of bias and independently extracted data. We used the GRADE approach to assess the certainty of evidence.

Main results: We included 19 studies with 2837 mother-infant pairs assessing vitamin D given to infants (nine studies), to lactating mothers (eight studies), and to infants versus lactating mothers (six studies). No studies compared vitamin D given to infants versus periods of infant sun exposure. Vitamin D supplementation given to infants: vitamin D at 400 IU/day may increase 25-OH vitamin D levels (MD 22.63 nmol/L, 95% CI 17.05 to 28.21; participants = 334; studies = 6; low-certainty) and may reduce the incidence of vitamin D insufficiency (25-OH vitamin D < 50 nmol/L) (RR 0.57, 95% CI 0.41 to 0.80; participants = 274; studies = 4; low-certainty). However, there was insufficient evidence to determine if vitamin D given to the infant reduces the risk of vitamin D deficiency (25-OH vitamin D < 30 nmol/L) up till six months of age (RR 0.41, 95% CI 0.16 to 1.05; participants = 122; studies = 2), affects bone mineral content (BMC), or the incidence of biochemical or radiological rickets (all very-low certainty). We are uncertain about adverse effects including hypercalcaemia. There were no studies of higher doses of infant vitamin D (> 400 IU/day) compared to placebo. Vitamin D supplementation given to lactating mothers: vitamin D supplementation given to lactating mothers may increase infant 25-OH vitamin D levels (MD 24.60 nmol/L, 95% CI 21.59 to 27.60; participants = 597; studies = 7; low-certainty), may reduce the incidences of vitamin D insufficiency (RR 0.47, 95% CI 0.39 to 0.57; participants = 512; studies = 5; low-certainty), vitamin D deficiency (RR 0.15, 95% CI 0.09 to 0.24; participants = 512; studies = 5; low-certainty) and biochemical rickets (RR 0.06, 95% CI 0.01 to 0.44; participants = 229; studies = 2; low-certainty). The two studies that reported biochemical rickets used maternal dosages of oral D3 60,000 IU/day for 10 days and oral D3 60,000 IU postpartum and at 6, 10, and 14 weeks. However, infant BMC was not reported and there was insufficient evidence to determine if maternal supplementation has an effect on radiological rickets (RR 0.76, 95% CI 0.18 to 3.31; participants = 536; studies = 3; very low-certainty). All studies of maternal supplementation enrolled populations at high risk of vitamin D deficiency. We are uncertain of the effects of maternal supplementation on infant growth and adverse effects including hypercalcaemia. Vitamin D supplementation given to infants compared with supplementation given to lactating mothers: infant vitamin D supplementation compared to lactating mother supplementation may increase infant 25-OH vitamin D levels (MD 14.35 nmol/L, 95% CI 9.64 to 19.06; participants = 269; studies = 4; low-certainty). Infant vitamin D supplementation may reduce the incidence of vitamin D insufficiency (RR 0.61, 95% CI 0.40 to 0.94; participants = 334; studies = 4) and may reduce vitamin D deficiency (RR 0.35, 95% CI 0.17 to 0.72; participants = 334; studies = 4) but the evidence is very uncertain. Infant BMC and radiological rickets were not reported and there was insufficient evidence to determine if maternal supplementation has an effect on infant biochemical rickets. All studies enrolled patient populations at high risk of vitamin D deficiency. Studies compared an infant dose of vitamin D 400 IU/day with varying maternal vitamin D doses from 400 IU/day to > 4000 IU/day. We are uncertain about adverse effects including hypercalcaemia.

Authors' conclusions: For breastfed infants, vitamin D supplementation 400 IU/day for up to six months increases 25-OH vitamin D levels and reduces vitamin D insufficiency, but there was insufficient evidence to assess its effect on vitamin D deficiency and bone health. For higher-risk infants who are breastfeeding, maternal vitamin D supplementation reduces vitamin D insufficiency and vitamin D deficiency, but there was insufficient evidence to determine an effect on bone health. In populations at higher risk of vitamin D deficiency, vitamin D supplementation of infants led to greater increases in infant 25-OH vitamin D levels, reductions in vitamin D insufficiency and vitamin D deficiency compared to supplementation of lactating mothers. However, the evidence is very uncertain for markers of bone health. Maternal higher dose supplementation (≥ 4000 IU/day) produced similar infant 25-OH vitamin D levels as infant supplementation of 400 IU/day. The certainty of evidence was graded as low to very low for all outcomes.

PubMed Disclaimer

Conflict of interest statement

MLT has no interest to declare.

SAA was an Advisory Board member for the Milk Processors Educational Program (MilkPep), and received consultancy as a scientific advisor. This relationship ended in December 2018.

DAO has no interest to declare.

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 given to infants compared to placebo or no treatment, Outcome 1: Bone mineral content at the end of intervention
1.2
1.2. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 2: Vitamin D insufficiency: 25‐OH vitamin D < 50 nmol/L
1.3
1.3. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 3: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L
1.4
1.4. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 4: Nutritional rickets: biochemical
1.5
1.5. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 5: Adverse effects (hypercalcaemia)
1.6
1.6. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 6: Adverse effects (others)
1.7
1.7. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 7: Serum 25‐OH vitamin D level at latest time reported to six months of age
1.8
1.8. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 8: Size at latest time measured: weight
1.9
1.9. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 9: Size at latest time measured: length
1.10
1.10. Analysis
Comparison 1: Vitamin D given to infants compared to placebo or no treatment, Outcome 10: Size at latest time measured: head circumference
2.1
2.1. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 1: Vitamin D insufficiency: 25‐OH vitamin D < 50 nmol/L
2.2
2.2. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 2: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L
2.3
2.3. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 3: Nutritional rickets: biochemical
2.4
2.4. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 4: Nutritional rickets: radiological
2.5
2.5. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 5: Adverse effects (hypercalcaemia)
2.6
2.6. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 6: Adverse effects (all)
2.7
2.7. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 7: Serum 25‐OH vitamin D level at latest time reported to six months of age
2.8
2.8. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 8: Change of standardised growth at latest time measured (weight) [z score]
2.9
2.9. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 9: Change of standardised growth at latest time measured (length) [z score]
2.10
2.10. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 10: Change of standardised growth at latest time measured (head circumference) [z score]
2.11
2.11. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 11: Size at latest time measured: weight
2.12
2.12. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 12: Size at latest time measured: length
2.13
2.13. Analysis
Comparison 2: Vitamin D given to lactating mothers compared to placebo or no treatment, Outcome 13: Size at latest time measured: head circumference
3.1
3.1. Analysis
Comparison 3: Vitamin D given to infants compared to vitamin D given to lactating mothers, Outcome 1: Vitamin D insufficiency: 25‐OH vitamin D < 50 nmol/L
3.2
3.2. Analysis
Comparison 3: Vitamin D given to infants compared to vitamin D given to lactating mothers, Outcome 2: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L
3.3
3.3. Analysis
Comparison 3: Vitamin D given to infants compared to vitamin D given to lactating mothers, Outcome 3: Nutritional rickets
3.4
3.4. Analysis
Comparison 3: Vitamin D given to infants compared to vitamin D given to lactating mothers, Outcome 4: Adverse effects (hypercalcaemia)
3.5
3.5. Analysis
Comparison 3: Vitamin D given to infants compared to vitamin D given to lactating mothers, Outcome 5: Serum 25‐OH vitamin D level at latest time reported to six months of age
3.6
3.6. Analysis
Comparison 3: Vitamin D given to infants compared to vitamin D given to lactating mothers, Outcome 6: Size at latest time measured: weight
3.7
3.7. Analysis
Comparison 3: Vitamin D given to infants compared to vitamin D given to lactating mothers, Outcome 7: Size at latest time measured: length
3.8
3.8. Analysis
Comparison 3: Vitamin D given to infants compared to vitamin D given to lactating mothers, Outcome 8: Size at latest time measured: head circumference
4.1
4.1. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 1: Bone mineral content at the end of intervention: subgroup analysis
4.2
4.2. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 2: Bone mineral content at the end of intervention: sensitivity analysis
4.3
4.3. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 3: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): infant risk
4.4
4.4. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 4: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): season of supplementation
4.5
4.5. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 5: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): D2 versus D3
4.6
4.6. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 6: Vitamin D insufficiency: 25‐OH vitamin D < 50 nmol/L: dosage
4.7
4.7. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 7: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): duration of supplementation
4.8
4.8. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 8: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): timing of commencement
4.9
4.9. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 9: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): sensitivity analysis
4.10
4.10. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 10: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: infant risk
4.11
4.11. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 11: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: season of supplementation
4.12
4.12. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 12: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: D2 versus D3
4.13
4.13. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 13: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: dosage
4.14
4.14. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 14: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: duration of supplementation
4.15
4.15. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 15: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: timing of commencement
4.16
4.16. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 16: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: sensitivity analysis
4.17
4.17. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 17: Nutritional rickets: biochemical: subgroup analysis
4.18
4.18. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 18: Nutritional rickets: biochemical: sensitivity analysis
4.19
4.19. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 19: Adverse effects (hypercalcaemia): subgroup and sensitivity analyses
4.20
4.20. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 20: Serum 25‐OH vitamin D level at latest time reported to six months of age: infant risk
4.21
4.21. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 21: Serum 25‐OH vitamin D level at latest time reported to six months of age: season of supplementation
4.22
4.22. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 22: Serum 25‐OH vitamin D level at latest time reported to six months of age: D2 versus D3
4.23
4.23. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 23: Serum 25‐OH vitamin D level at latest time reported to six months of age: dosage
4.24
4.24. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 24: Serum 25‐OH vitamin D level at latest time reported to six months of age: duration of supplementation
4.25
4.25. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 25: Serum 25‐OH vitamin D level at latest time reported to six months of age: timing of commencement
4.26
4.26. Analysis
Comparison 4: Vitamin D given to infants compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 26: Serum 25‐OH vitamin D level at latest time reported to six months of age: sensitivity analysis
5.1
5.1. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 1: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): infant risk
5.2
5.2. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 2: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): season of supplementation
5.3
5.3. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 3: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): D2 versus D3
5.4
5.4. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 4: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): dosage
5.5
5.5. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 5: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): duration of supplementation
5.6
5.6. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 6: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): timing of commencement
5.7
5.7. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 7: Vitamin D insufficiency (25‐OH vitamin D < 50 nmol/L): sensitivity analysis
5.8
5.8. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 8: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: infant risk
5.9
5.9. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 9: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: season of supplementation
5.10
5.10. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 10: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: D2 versus D3
5.11
5.11. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 11: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: dosage
5.12
5.12. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 12: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: duration of supplementation
5.13
5.13. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 13: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: timing of commencement
5.14
5.14. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 14: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: sensitivity analysis
5.15
5.15. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 15: Nutritional rickets: biochemical: subgroup analyses
5.16
5.16. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 16: Nutritional rickets: biochemical: sensitivity analysis
5.17
5.17. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 17: Nutritional rickets: radiological: infant risk
5.18
5.18. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 18: Nutritional rickets: radiological: season of supplementation
5.19
5.19. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 19: Nutritional rickets: radiological: D2 versus D3
5.20
5.20. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 20: Nutritional rickets: radiological: dosage
5.21
5.21. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 21: Nutritional rickets: radiological: duration of supplementation
5.22
5.22. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 22: Nutritional rickets: radiological: timing of commencement
5.23
5.23. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 23: Nutritional rickets: radiological: sensitivity analysis
5.24
5.24. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 24: Adverse effects (hypercalcaemia): subgroup analyses
5.25
5.25. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 25: Adverse effects (hypercalcaemia): sensitivity analysis
5.26
5.26. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 26: Serum 25‐OH vitamin D level at latest time reported to six months of age: infant risk
5.27
5.27. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 27: Serum 25‐OH vitamin D level at latest time reported to six months of age: season of supplementation
5.28
5.28. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 28: Serum 25‐OH vitamin D level at latest time reported to six months of age: D2 versus D3
5.29
5.29. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 29: Serum 25‐OH vitamin D level at latest time reported to six months of age: dosage
5.30
5.30. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 30: Serum 25‐OH vitamin D level at latest time reported to six months of age: duration of supplementation
5.31
5.31. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 31: Serum 25‐OH vitamin D level at latest time reported to six months of age: timing of commencement
5.32
5.32. Analysis
Comparison 5: Vitamin D given to lactating mothers compared to placebo or no treatment: subgroup and sensitivity analyses, Outcome 32: Serum 25‐OH vitamin D level at latest time reported to six months of age: sensitivity analysis
6.1
6.1. Analysis
Comparison 6: Vitamin D given to infants compared to vitamin D given to lactating mothers: sensitivity analysis, Outcome 1: Vitamin D insufficiency: 25‐OH vitamin D < 50 nmol/L: subgroup analysis
6.2
6.2. Analysis
Comparison 6: Vitamin D given to infants compared to vitamin D given to lactating mothers: sensitivity analysis, Outcome 2: Vitamin D insufficiency: 25‐OH vitamin D < 50 nmol/L: sensitivity analysis
6.3
6.3. Analysis
Comparison 6: Vitamin D given to infants compared to vitamin D given to lactating mothers: sensitivity analysis, Outcome 3: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: subgroup analysis
6.4
6.4. Analysis
Comparison 6: Vitamin D given to infants compared to vitamin D given to lactating mothers: sensitivity analysis, Outcome 4: Vitamin D deficiency: 25‐OH vitamin D < 30 nmol/L: sensitivity analysis
6.5
6.5. Analysis
Comparison 6: Vitamin D given to infants compared to vitamin D given to lactating mothers: sensitivity analysis, Outcome 5: Nutritional rickets: biochemical: sensitivity analysis
6.6
6.6. Analysis
Comparison 6: Vitamin D given to infants compared to vitamin D given to lactating mothers: sensitivity analysis, Outcome 6: Adverse effects (hypercalcaemia): subgroup and sensitivity analyses
6.7
6.7. Analysis
Comparison 6: Vitamin D given to infants compared to vitamin D given to lactating mothers: sensitivity analysis, Outcome 7: Serum 25‐OH vitamin D level at latest time reported to six months of age: subgroup analysis
6.8
6.8. Analysis
Comparison 6: Vitamin D given to infants compared to vitamin D given to lactating mothers: sensitivity analysis, Outcome 8: Serum 25‐OH vitamin D level at latest time reported to six months of age: sensitivity analysis
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References

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    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] [PMID: ] - DOI - PMC - PubMed
Naik 2017 {published data only}
    1. Naik P, Faridi MM, Batra P, Madhu SV. Oral supplementation of parturient mothers with vitamin D and its effect on 25OHD status of exclusively breastfed infants at 6 months of age: a double-blind randomized placebo controlled trial. Breastfeeding Medicine 2017;12(10):621-8. [DOI: 10.1089/bfm.2016.0164] [PMID: ] - DOI - PubMed
Niramitmahapanya 2017 {published data only}
    1. Niramitmahapanya S, Kaoiean S, Sangtawesin V, Bordeerat NK, Deerochanawong C. Correlation of 25-hydroxyvitamin D levels in serum vs breastmilk in vitamin D-supplementation breastfeeding women during lactation: randomized double blinded control trial. In: Endocrine Reviews. Conference: 99th Annual Meeting of the Endocrine Society, ENDO 2017. United States. Vol. 38. 2017. - PubMed
    1. Niramitmahapanya S, Kaoiean S, Sangtawesin V, Patpanaprapan A, Bordeerat NK. Maternal vitamin D3 supplementation during lactation ameliorate vitamin D status of breast-fed infants: randomized controlled trial. In: Endocrine Reviews. Conference: 97th Annual Meeting and Expo of the Endocrine Society, ENDO 2015. United States. Vol. 36. 2015.
    1. NCT02297568. Vitamin D supplementation during lactation [Randomized control trial of vitamin D supplementation during lactation on vitamin D in maternal milk]. clinicaltrials.gov/ct2/show/NCT02297568 (first received 21 November 2014).
    1. Niramitmahapanya S, Kaoiean S, Sangtawesin V, Patanaprapan A, Bordeerat NK, Deerochanawong C. Correlation of 25-hdroxyvitamin D levels in serum vs. breastmilk in vitamin D-supplementation breastfeeding women during lactation: randomized double blinded control trial. Journal of the Medical Association of Thailand 2017;100(Suppl 1):S165-71. [PMID: ] - PubMed
    1. Niramitmahapanya S, Kaoiean S, Sangtawesin V, Patpanaprapan A, Bordeerat NK, Deerochanawong C. Effect on vitamin D status of breastfeeding infants after vitamin D3 supplementation during breastfeeding lactation: a double-blind randomized controlled trial. Annals of Clinical Endorinology and Metabolism 2017;1:6-14. [DOI: 10.29328/journal.hcem.1001002] - DOI
Ponnapakkam 2010 {published data only}
    1. Bradford EM, Gensure R, Ponnapakkam T. Vitamin D supplementation in the breastfed infants: preliminary results of a prospective trial. Journal of Investigative Medicine 2010;58:448.
    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:S232.
Roth 2016 {published data only}
    1. NCT03537443. Bone and muscle health in kids (BONUSKids) [Effect of maternal vitamin D supplementation during pregnancy on offspring bone mass, body composition and muscle strength in early childhood: follow-up of a randomized controlled trial cohort.]. clinicaltrialsgov/show/NCT03537443 (first received 25 May 2018).
    1. Roth D, Mahmud AA, Morris S, Zlotkin S, Gernand A, Tahmeed A, et al. Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): a randomized controlled trial. Annals of Nutrition and Metabolism 2017;71:571. - PMC - PubMed
    1. Roth DE, Gernand AD, Morris SK, Pezzack B, Islam MM, Dimitris MC, et al. Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial. Trials 2015;16:300. [DOI: 10.1186/s13063-015-0825-8] [PMID: ] - DOI - PMC - PubMed
    1. Roth DE, Morris SK, Zlotkin S, Gernand AD, Ahmed T, Shanta SS, et al. Vitamin D supplementation in pregnancy and lactation and infant growth. New England Journal of Medicine 2018;379(6):535-46. [DOI: 10.1056/NEJMoa1800927] [DOI: ] - DOI - PMC - PubMed
Rothberg 1982 {published data only}
    1. Rothberg AD, Pettifor JM, Cohen DF, Sonnendecker EW, Ross FP. Maternal-infant vitamin D relationships during breast-feeding. Journal of Pediatrics 1982;101(4):500-3. [DOI: 10.1016/s0022-3476(82)80689-6] [PMID: ] - DOI - PubMed
Rueter 2019 {published data only}
    1. Kristina K, Jones AP, Siafarikas A, Lim E-M, Prescott SL, Palmer DJ. In "high-risk" infants with sufficient vitamin D status at birth, infant vitamin D supplementation had no effect on allergy outcomes: a randomized controlled trial. Nutrients 2020;12(6):1747. [DOI: 10.3390/nu12061747] [PMID: ] - DOI - PMC - PubMed
    1. Leffler J, Gamez C, Jones AP, Rueter K, Read JF, Siafarikas A, et al. In infants with sufficient vitamin D status at birth, vitamin D supplementation does not impact immune development. Pediatric Allergy and Immunology 2020;31(6):686–94. [DOI: 10.1111/pai.13250] [PMID: ] - DOI - PubMed
    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. [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. Does early oral vitamin d supplementation and UV-light exposure have an impact on allergic disease outcome in infancy? Internal Medicine Journal 2019;49(Suppl 4):35.
Thiele 2017 {published data only}
    1. Anderson CM, Gillespie SL, Thiele DK, Ralph JL, Ohm JE. Effects of maternal vitamin D supplementation on the maternal and infant epigenome. Breastfeeding Medicine 2018;13(5):371-80. [DOI: 10.1089/bfm.2017.0231] [PMID: ] - DOI - PMC - PubMed
    1. Anderson CM, Thiele DK, Ralph JL, Perley D, Ohm JE. Vitamin D supplementation and DNA methylation patterns during pregnancy and lactation in mothers and infants. Federation of American Societies for Experimental Biology Journal 2016;30(S!):1028.3. [DOI: 10.1096/fasebj.30.1_supplement.1028.3] - DOI
    1. Thiele DK, Ralph J, El-Masri M, Anderson CM. Vitamin D3 supplementation during pregnancy and lactation improves vitamin D status of the mother-infant dyad. Journal of Obstetric, Gynecologic, and Neonatal Nursing 2017;46(1):135-47. [DOI: 10.1016/j.jogn.2016.02.016] [PMID: ] - DOI - PubMed
Trivedi 2020 {published data only}
    1. Trivedi M, Faridi MM, Aggarwal A, Madhu SV, Malhotra RK. Oral vitamin D supplementation to mothers during lactation - effect of 25(OH)D concentration on exclusively breastfed infants at 6 months of age: a randomized double-blind placebo-controlled trial. Breastfeeding Medicine 2020;15:237-45. [DOI: 10.1089/bfm.2019.0102] [PMID: ] - DOI - PubMed
Wagner 2006 {published data only}
    1. Wagner CL, Hulsey TC, Fanning D, Ebeling M, Hollis BW. High-dose vitamin D3 supplementation in a cohort of breastfeeding mothers and their infants: a 6-month follow-up pilot study. Breastfeeding Medicine 2006;1:59-70. [DOI: 10.1089/bfm.2006.1.59] [PMID: ] - DOI - PubMed
Wheeler 2016 {published data only}
    1. Wheeler BJ, Taylor BJ, Herbison P, Haszard JJ, Mikhail A, Jones S, et al. Effect of high dose monthly maternal cholecalciferol supplementation during breastfeeding on infant and maternal vitamin d status at 5 months post-partum: a randomized controlled trial. International Journal of Pediatric Endocrinology 2017;2017 (Suppl 1)(15):35.
    1. Wheeler BJ, Taylor BJ, Herbison P, Haszard JJ, Mikhail A, Jones S, et al. High-dose monthly maternal cholecalciferol supplementation during breastfeeding affects maternal and infant vitamin D status at 5 months postpartum: a randomized controlled trial. Journal of Nutrition 2016;146(10):1999-2006. [DOI: 10.3945/jn.116.236679] [PMID: ] - DOI - PubMed

References to studies excluded from this review

Abdel‐Hady 2019 {published data only}
    1. Abdel-Hady H, Yahia S, Megahed A, Mosbah A, Seif B, Nageh E, et al. Mediators in preterm infants with late-onset sepsis: a randomized controlled trial. Journal of Pediatric Gastroenterology and Nutrition 2019;68(4):578-84. [DOI: 10.1097/MPG.0000000000002238] [PMID: ] - DOI - PubMed
ACTRN12613000732785 {published data only}
    1. ACTRN12613000732785. The efficacy of vitamin D supplementation in infants on bone mineral content: a double blind randomized controlled trial [Vitamin D infant bone mineral content study]. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613000732785 (first received 20 June 2013).
ACTRN12618001174279 {published data only}
    1. ACTRN12618001174279. Vitamin D supplementation to prevent acute respiratory infections among Indigenous children in the Northern Territory: a randomised controlled trial. anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375278 (first received 9 July 2018).
Al‐Beltagi 2020 {published data only}
    1. Al-Beltagi M, Rowiesha M, Elmashad A, Elrifaey SM, Elhorany H, Koura HG. Vitamin D status in preterm neonates and the effects of its supplementation on respiratory distress syndrome. Pediatric Pulmonology 2020;55(1):108-15. [DOI: 10.1002/ppul.24552] [PMID: ] - DOI - PubMed
Backstrom 1999 {published data only}
    1. Backstrom MC, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Koskinen M, et al. The long-term effect of early mineral, vitamin D, and breast milk intake on bone mineral status in 9- to 11-year-old children born prematurely. Journal of Pediatric Gastroenterology and Nutrition 1999;29(5):575-82. [DOI: 10.1097/00005176-199911000-00019] [PMID: ] - DOI - PubMed
Bagnoli 2013 {published data only}
    1. Bagnoli F, Casucci M, Toti S, Cecchi S, Iurato C, Coriolani G, et al. Is vitamin D supplementation necessary in healthy full-term breastfed infants? A follow-up study of bone mineralization in healthy full-term infants with and without supplemental vitamin D. Minerva Pediatrica 2013;65(3):253-60. [PMID: ] - PubMed
Baird 2016 {published data only}
    1. Baird J, Barker M, Harvey NC, Lawrence W, Vogel C, Jarman M, et al. Southampton PRegnancy Intervention for the Next Generation (SPRING): protocol for a randomised controlled trial. Trials 2016;17(1):493. [DOI: 10.1186/s13063-016-1603-y] [PMID: ] - DOI - PMC - PubMed
Basile 2006 {published data only}
    1. Basile LA, Taylor SN, Wagner CL, Horst RL, Hollis BW. The effect of high-dose vitamin D supplementation on serum vitamin D levels and milk calcium concentration in lactating women and their infants. Breastfeeding Medicine 2006;1(1):27-35. [DOI: 10.1089/bfm.2006.1.27] [PMID: ] - DOI - PubMed
Bugrul 2013 {published data only}
    1. Bugrul F, Devecioglu E, Ozden T, Gokcay G, Omer B. Effect of maternal and infant vitamin D supplementation on vitamin D levels of breastfed infants. Turkish Journal of Pediatrics 2013;55(2):158-63. [PMID: ] - PubMed
Challa 2005 {published data only}
    1. Challa A, Ntourntoufi A, Cholevas V, Bitsori M, Galanakis E, Andronikou S. Breastfeeding and vitamin D status in Greece during the first 6 months of life. European Journal of Pediatrics 2005;164(12):724-9. [DOI: 10.1007/s00431-005-1757-1] [PMID: ] - DOI - PubMed
Chan 1982 {published data only}
    1. Chan GM, Roberts CC, Folland D, Jackson R. Growth and bone mineralization of normal breast-fed infants and the effects of lactation on maternal bone mineral status. American Journal of Clinical Nutrition 1982;36(3):438-43. [DOI: 10.1093/ajcn/36.3.438] [PMID: ] - DOI - PubMed
Chawes 2016 {published data only}
    1. Brustad N, Eliasen A, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. High-dose vitamin D supplementation during pregnancy and asthma at age 6: a randomized controlled trial. Allergy: European Journal of Allergy and Clinical Immunology 2019;74(Suppl 106):60. [DOI: 10.1001/jama.2019.0052] [PMID: ] - DOI - PMC - PubMed
    1. Chawes BL, Bonnelykke K, Stokholm J, Vissing NH, Bjarnadottir E, Schoos AM, et al. Effect of vitamin D3 supplementation during pregnancy on risk of persistent wheeze in the offspring: a randomized clinical trial. JAMA 2016;315(4):353-61. [DOI: 10.1001/jama.2015.18318] [PMID: ] - DOI - PubMed
    1. Hjelmso MH, Shah SA, Thorsen J, Rasmussen M, Vestergaard G, Mortensen MS, et al. Prenatal dietary supplements influence the infant airway microbiota in a randomized factorial clinical trial. Nature Communications 2020;11(1):426. [DOI: 10.1038/s41467-020-14308-x] [PMID: ] - DOI - PMC - PubMed
    1. Kofod Vinding R, Stokholm J, Sevelsted A, Chawes BL, Bonnelykke K, Barman M, et al. Fish oil supplementation in pregnancy increases gestational age, size for gestational age, and birth weight in infants: a randomized controlled trial. Journal of Nutrition 2019;149(4):628-34. [DOI: 10.1093/jn/nxy204] [PMID: ] - DOI - PubMed
Cooper 2016 {published data only}
    1. Bishop NJ, Kennedy S, Papageorghiou AT, Fraser R, Gandhi SV, D'Angelo S, et al. Maternal gestational vitamin D supplementation and offspring bone mass: a multicentre randomised, double-blind, placebo-controlled trial (MAVIDOS). In: Journal of Bone and Mineral Research. Conference: 2015 Annual Meeting of the American Society for Bone and Mineral Research, ASBMR 2015. United States. Vol. 30. 2015.
    1. Cooper C, Harvey NC, Bishop NJ, Kennedy S, Papageorghiou AT, Schoenmakers I, et al, MAVIDOS Study Group. Maternal gestational vitamin D supplementation and offspring bone health (MAVIDOS): a multicentre, double-blind, randomised placebo-controlled trial. Lancet Diabetes and Endocrinology 2016;4:393-402. [DOI: 10.1016/S2213-8587(16)00044-9] [PMID: ] - DOI - PMC - PubMed
Czech‐Kowalska 2013 {published data only}
    1. Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Chazan B, et al. Influence of vitamin D supplementation on vitamin D status and bone mass during lactation - double blinded randomized control trial. In: Annals of Nutrition & Metabolism. Vol. 63. 2013:796.
    1. Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Wygledowska G, et al. Impact of vitamin D supplementation during lactation on vitamin D status and body composition of mother-infant pairs: a MAVID randomized controlled trial. PLOS One 2014;9(9):e107708. [DOI: 10.1371/journal.pone.0107708] [PMID: ] - DOI - PMC - PubMed
    1. Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Wygledowska G, Chazan B, et al. Influence of vitamin D supplementation in lactating mothers on their and offspring's vitamin D status and bone mass - double blinded randomized control trial - MAVID study. Journal of Perinatal Medicine 2013;41(S1):594.
Dawudo 2019 {published data only}
    1. Dawodu A, Salameh K, Reedy A. Very low human milk vitamin D in breastfeeding mothers in an environment with abundant sunlight. In: FASEB Journal. Conference: Experimental Biology 2016, EB. San Diego, CA United States. Vol. 30. 2016.
    1. Dawodu A, Salameh KM, Al-Janahi NS, Bener A, Elkum N. The effect of high-dose postpartum maternal vitamin D supplementation alone compared with maternal plus infant vitamin D supplementation in breastfeeding infants in a high-risk population. A randomized controlled trial. Nutrients 2019;11(7):1632. [DOI: 10.3390/nu11071632] [PMID: ] - DOI - PMC - PubMed
    1. Salameh K, Dawodu AH. Randomized controlled study of effectiveness and safety of high dose vitamine D supplementation on breast milk v D limited sun. In: Journal of Pediatric Gastroenterology and Nutrition. Conference: 51st Annual Meeting European Society for Paediatric Gastroenterology, Hepatology and Nutrition, ESPGHAN 2018. Switzerland. Vol. 66. 2018:1097.
Delvin 2005 {published data only}
    1. Delvin EE, Salle BL, Claris O, Putet G, Hascoet JM, Desnoulez L, et al. Oral vitamin A, E and D supplementation of pre-term newborns either breast-fed or formula-fed: a 3-month longitudinal study. Journal of Pediatric Gastroenterology and Nutrition 2005;40(1):43-7. [DOI: 10.1097/00005176-200501000-00008] [PMID: ] - DOI - PubMed
Diogenes 2013 {published data only}
    1. Diogenes ME, Bezerra FF, Rezende EP, Donangelo CM. Calcium plus vitamin D supplementation during the third trimester of pregnancy in adolescents accustomed to low calcium diets does not affect infant bone mass at early lactation in a randomized controlled trial. Journal of Nutrition 2015;145(7):1515-23. [DOI: 10.3945/jn.114.208140] [PMID: ] - DOI - PubMed
    1. Diogenes ME, Bezerra FF, Rezende EP, Taveira MF, Normando P, Pinhal I, et al. Infant and maternal bone status are associated in lactating adolescents when calcium intake is low but not following calcium plus vitamin D supplementation. Federation of American Societies for Experimental Biology Journal 2013;27:850.5. [DOI: 10.1096/fasebj.27.1_supplement.850.5] - DOI
    1. Diogenes ME, Bezerra FF, Rezende EP, Taveira MF, Pinhal I, Donangelo CM. Effect of calcium plus vitamin D supplementation during pregnancy in Brazilian adolescent mothers: a randomized, placebo-controlled trial. American Journal of Clinical Nutrition 2013;98(1):82-91. [DOI: 10.3945/ajcn.112.056275] [PMID: ] - DOI - PubMed
    1. Diogenes ME, Bezerra FF, Rezende EP, Taveira MF, Pinhal I, Donangelo CM. Maternal vitamin D status of adolescent mothers at mid-pregnancy influence bone mineral content of their newborns. Federation of American Societies for Experimental Biology Journal 2011;25:603.19. [DOI: 10.1096/fasebj.25.1_supplement.603.19] - DOI
Francis 2018 {published data only}
    1. Francis J, Unger S, Bando N, Vance A, Gibbins S, Kiss A, et al, GTA-DoMINO Feeding Group. Postdischarge feeding of very-low-birth-weight infants: adherence to nutrition guidelines. Journal of Pediatric Gastroenterology and Nutrition 2018;67(3):401-8. [DOI: 10.1097/MPG.0000000000002041] [PMID: ] - DOI - PubMed
Galdo 2018 {published data only}
    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. In: European Respiratory Journal. Conference: European Respiratory Society International Congress, ERS 2018. France. Vol. 52. 2018.
Gallo 2013a {published data only}
    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. In: Journal of Bone and Mineral Research. Conference: 2011 Annual Meeting of the American Society for Bone and Mineral Research, ASBMR 2011. San Diego, CA United States. Vol. 26. 2011.
    1. Gallo S, Comeau K, Sharma A, Vanstone CA, Agellon S, Mitchell J, et al. Redefining normal bone and mineral clinical biochemistry reference intervals for healthy infants in Canada. Clinical Biochemistry 2014;47(15):27-32. [DOI: 10.1016/j.clinbiochem.2014.07.012] [PMID: ] - DOI - PubMed
    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;309:1785-92. [DOI: 10.1001/jama.2013.3404] [PMID: ] - PubMed
    1. Gallo S, Hazell T, Vanstone CA, Agellon S, Jones G, L'Abbe M, et al. Vitamin D supplementation in breastfed infants from Montreal, 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, Vanstone CA, Comeau K, Agellon S, Rodd C, Sharma A, et al. Vitamin D dose response study in canadian infants: 25-Hydroxy-vitamin D status during a 20 week intervention. In: Federation of American Socieities for Experimental Biology Journal. Vol. 24. 2010. [DOI: 10.1096/fasebj.24.1_supplement.537.11] - DOI
Gallo 2013b {published data only}
    1. Gallo S, Phan A, Vanstone CA, Rodd C, Weiler HA. The change in plasma 25-hydroxyvitamin D did not differ between breast-fed infants that received a daily supplement of ergocalciferol or cholecalciferol for 3 months. Journal of Nutrition 2013;143(2):148-53. [DOI: 10.3945/jn.112.167858] [PMID: ] - DOI - PMC - PubMed
Grant 2014 {published data only}
    1. Grant CC, Stewart AW, Scragg R, Milne T, Rowden J, Ekeroma A, et al. Vitamin D during pregnancy and infancy and infant serum 25-hydroxyvitamin D concentration. Pediatrics 2014;133(1):e143-e53. [DOI: 10.1542/peds.2013-2602] [PMID: ] - DOI - PubMed
    1. Wall CR, Stewart AW, Camargo CA Jr, Scragg R, Mitchell EA, Ekeroma A. Vitamin D activity of breast milk in women randomly assigned to vitamin D3 supplementation during pregnancy. American Journal of Clinical Nutrition 2016;103(2):382-8. [DOI: 10.3945/ajcn.115.114603] [PMID: ] - DOI - PubMed
Gupta 2018 {published data only}
    1. Gupta T, Sharma H, Bajpai J, Kachhawa G, Kulshreshtha V, Khadgawat R, et al. A randomized double blind controlled trial to investigate the effects of vitamin D supplementation on maternal and new-born baby's vitamin D status in Asian-Indian subjects. Indian Journal of Endocrinology and Metabolism 2018;22(7 Suppl 1):S89.
Hibbs 2018 {published data only}
    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:S250-S1. - 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. [DOI: 10.1001/jama.2018.5729] [PMID: ] - DOI - PMC - PubMed
Ho 1985 {published data only}
    1. Ho ML, Yen HC, Tsang RC, Specker BL, Chen XC, Nichols BL. Randomized study of sunshine exposure and serum 25-OHD in breast-fed infants in Beijing, China. Journal of Pediatrics 1985;107(6):928-31. [DOI: 10.1016/s0022-3476(85)80192-x] [PMID: ] - DOI - PubMed
Hollis 2004 {published data only}
    1. Hollis BW, Wagner CL. Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant. American Journal of Clinical Nutrition 2004;80(6 Suppl):1752s-8s. [DOI: 10.1093/ajcn/80.6.1752S] [PMID: ] - DOI - PubMed
Huynh 2015 {published data only}
    1. Huynh J, Lu T, Liew D, Doery J, Tudball R, Jona M, et al. The Vine study: vitamin D in newborns: an RCT comparing daily and bolus supplementation. In: Journal of Paediatrics and Child Health. Conference: 19th Annual Meeting of the Perinatal Society of Australia and New Zealand, PSANZ 2015. Melbourne, VIC Australia. Vol. 51; S1. 2015:30-1.
    1. ACTRN12613001234707. 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 [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 mother]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613001234707 (first received 9 October 2013).
    1. Huynh J, Liew D, Rodda C. Neonatal vitamin D supplementation. Journal of Paediatrics and Child Health 2017;53(7):725-6. [DOI: 10.1111/jpc.13582] [PMID: ] - PubMed
    1. Huynh J, Lu T, Liew D, Doery JC, Tudball R, Jona M, et al. Vitamin D in newborn. 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: 27670154] - DOI - PubMed
Ketha 2018 {published data only}
    1. Ketha H, Thacher TD, Oberhelman SS, Fischer PR, Singh RJ, Kumar R. Comparison of the effect of daily versus bolus dose maternal vitamin D3 supplementation on the 24,25-dihydroxyvitamin D3 to 25-hydroxyvitamin D3 ratio. Bone 2018;110:321-5. [DOI: 10.1016/j.bone.2018.02.024] [PMID: ] - DOI - PMC - PubMed
Kishore 2019 {published data only}
    1. Kishore SS, Gadiraju M. Study of daily vitamin D supplementation in preterm infants: a randomized trial. Journal of Pediatric Gastroenterology and Nutrition 2019;68:1167.
Kolodziejczyk 2017 {published data only}
    1. Kolodziejczyk 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] [PMID: ] - DOI - PMC - PubMed
Kuryaninova 2017 {published data only}
    1. Kuryaninova V, Dolbnya S, Kasyanova A, Yagupova A, Zakharova I, Klimov L, et al. B-defensin level changes over time in children under three years of age receiving cholecalciferol. Journal of Pediatric Gastroenterology and Nutrition 2017;64:988.
Lara‐Corrales 2013 {published data only}
    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;30:638.
Litonjua 2014 {published data only}
    1. Lu M, Carey VJ, O'Connor GT, Bacharier LB, Zeiger RS, Hollis B, et al. Prenatal and neonatal vitamin D sufficiency are associated with reduced risk of childhood asthma/recurrent wheeze. In: American Journal of Respiratory and Critical Care Medicine. Conference: American Thoracic Society International Conference, ATS 2018. United States. Vol. 197. 2018.
    1. Mirzakhani H, O'Connor GT, Bacharier L, Zeiger RS, Schatz MX, Weiss S, et al. Asthma control status during pregnancy and its relationship with vitamin D level: an observation from the vitamin D antenatal asthma reduction trial (VDAART). In: American Journal of Respiratory and Critical Care Medicine. Conference: American Thoracic Society International Conference, ATS 2017. United States. Vol. 195. 2017.
    1. Hornsby E, Pfeffer PE, Laranjo N, Cruikshank W, Tuzova M, Litonjua AA, et al. Vitamin D supplementation during pregnancy: effect on the neonatal immune system in a randomized controlled trial. Journal of Allergy and Clinical Immunology 2018;141(1):269-78. [DOI: 10.1016/j.jaci.2017.02.039] [PMID: ] - DOI - PubMed
    1. Litonjua AA, Carey VJ, Laranjo N, Harshfield BJ, McElrath TF, O'Connor GT, et al. Effect of prenatal supplementation with Vitamin D on asthma or recurrent wheezing in offspring by age 3 years: the VDAART randomized clinical trial. JAMA 2016;315(4):362-70. [DOI: 10.1001/jama.2015.18589] [PMID: ] - DOI - PMC - PubMed
    1. Litonjua AA, Lange NE, Carey VJ, Brown S, Laranjo N, Harshfield BJ, et al. The Vitamin D Antenatal Asthma Reduction Trial (VDAART): rationale, design, and methods of a randomized, controlled trial of vitamin D supplementation in pregnancy for the primary prevention of asthma and allergies in children. Contemporary Clinical Trials 2014;38(1):37-50. [DOI: 10.1016/j.cct.2014.02.006] [PMID: ] - DOI - PMC - PubMed
March 2015 {published data only}
    1. Barr SI, Lyon MR, Whiting SJ, Weiler HA, Green TJ. Maternal vitamin D₃ supplementation at 50 μg/d protects against low serum 25-hydroxyvitamin D in infants at 8 wk of age: a randomized controlled trial of 3 doses of vitamin D beginning in gestation and continued in lactation. American Journal of Clinical Nutrition 2015;102(2):402-10. [DOI: 10.3945/ajcn.114.106385] [PMID: 27802998 ] - DOI - PubMed
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    1. March KM, Chen NN, Karakochuk CD, Shand AW, Innis SM, Von Dadelszen P, Barr SI, Lyon MR, Whiting SJ, Weiler HA, Green TJ. Maternal vitamin D3 supplementation at 50 mg/d protects against low serum 25-hydroxyvitamin D in infants at 8 wk of age: A randomized controlled trial of 3 doses of vitamin D beginning in gestation and continued in lactation. American Journal of Clinical Nutrition 2015;102:402-10; erratum (American Journal of Clinical Nutrition (2015) 102 (402-410).. - PubMed
Mirghafourvand 2015 {published data only}
    1. Mansouri A, Mirghafourvand M, Charandabi SM, Najafi M. The effect of vitamin D and calcium plus vitamin D on leg cramps in pregnant women: a randomized controlled trial. Journal of Research in Medical Sciences 2017;22:24. [DOI: 10.4103/1735-1995.200271] [PMID: ] - DOI - PMC - PubMed
    1. Mirghafourvand M, Mohammad-Alizadeh-Charandabi S, Mansouri A, Najafi M, Khodabande F. The effect of vitamin D and calcium plus vitamin D on sleep quality in pregnant women with leg cramps: a controlled randomized clinical trial. Journal of Isfahan Medical School 2015;32(320):2444-53. [CENTRAL: CN-01070330]
    1. Mohammad-Alizadeh-Charandabi S, Mirghafourvand M, Mansouri A, Najafi M, Khodabande F. The effect of vitamin D and calcium plus vitamin D during pregnancy on pregnancy and birth outcomes: a randomized controlled trial. Journal of Caring Sciences 2015;4(1):35-44. [DOI: 10.5681/jcs.2015.004] [PMID: ] - DOI - PMC - PubMed
Morris 2017 {published data only}
    1. Morris SK, Pell LG, Rahman MZ, Dimitris MC, Mahmud A, Islam MM, et al. Maternal vitamin D supplementation during pregnancy and lactation to prevent acute respiratory infections in infancy in Dhaka, Bangladesh (MDARI trial): protocol for a prospective cohort study nested within a randomized controlled trial. BMC Pregnancy and Childbirth 2016;16(1):309. [DOI: 10.1186/s12884-016-1103-9] [PMID: ] - DOI - PMC - PubMed
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Nausheen 2018 {published data only}
    1. Nausheen S, Soofi S. Assessment of dose effectiveness of vitamin D supplementation during pregnancy. A dose comparison clinical trial. BJOG: An International Journal of Obstetrics and Gynaecology 2018;125:15.
NCT02713009 {published data only}
    1. NCT02713009. Impact of maternal body weight on vitamin D status during pregnancy (MO-VITD) [Investigation of the impact of maternal body weight on vitamin D status during pregnancy: a randomised supplementation study]. clinicaltrials.gov/ct2/show/NCT02713009 (first received 18 March 2016).
Norizoe 2014 {published data only}
    1. Norizoe C, Akiyama N, Segawa T, Tachimoto H, Mezawa H, Ida H, et al. Increased food allergy and vitamin D: randomized, double-blind, placebo-controlled trial. Pediatrics International 2014;56(1):6-12. [DOI: 10.1111/ped.12207] [PMID: ] - DOI - PubMed
O'Callaghan 2018 {published data only}
    1. O'Callaghan KM, Hennessy A, Hull GL, Healy K, Ritz C, Kenny LC, et al. Estimation of the maternal vitamin D intake that maintains circulating 25-hydroxy vitamin D in late gestation at a concentration sufficient to keep umbilical cord sera >= 25-30 nmol/L: a dose-response, double-blind, randomized placebo-controlled trial in pregnant women at northern latitude. American Journal of Clinical Nutrition 2018;108(1):77-91. [DOI: 10.1093/ajcn/nqy064] [PMID: ] - DOI - PMC - PubMed
Oberhelman 2013 {published data only}
    1. Ketha H, Thacher TD, Oberhelman SS, Fischer PR, Singh RJ, Kumar R. Comparison of the effect of daily versus bolus dose maternal vitamin D3 supplementation on the 24,25-dihydroxyvitamin D3 to 25-hydroxyvitamin D3 ratio. Bone 2018;110:321-5. [DOI: 10.1016/j.bone.2018.02.024] [PMID: ] - DOI - PMC - PubMed
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    1. Oberhelman SS, Meekins ME, Fischer PR, Lee BR, Singh RJ, Cha SS, et al. Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial. Mayo Clinic Proceedings 2013;88(12):1378-87. [DOI: 10.1016/j.mayocp.2013.09.012] [PMID: ] - PMC - PubMed
Onal 2010 {published data only}
    1. Onal H, Adal E, Alpaslan S, Ersen A, Aydin A. Is daily 400 IU of vitamin D supplementation appropriate for every country: a cross-sectional study. European Journal of Nutrition 2010;49(7):395-400. [DOI: 10.1007/s00394-010-0097-8] [PMID: ] - DOI - PubMed
Perumal 2017 {published data only}
    1. Perumal N, Mahmud A, Baqui A, Roth D. Prenatal vitamin D supplementation and infant vitamin D status in Bangladesh. In: FASEB Journal. Conference: Experimental Biology 2014, EB. San Diego, CA United States. Vol. 28. 2014.
    1. Roth DE, Al Mahmud A, Raqib R, Akhtar E, Perumal N, Pezzack B, et al. Randomized placebo-controlled trial of high-dose prenatal third-trimester vitamin D3 supplementation in Bangladesh: the AViDD trial. Nutrition Journal 2013;12:1-16. - PMC - PubMed
    1. Dimitris MC, Perumal N, Craig-Barnes HA, Leadley M, Mahmud AA, Baqui AH, et al. Effect of weekly high-dose vitamin D3 supplementation on serum cholecalciferol concentrations in pregnant women. Journal of Steroid Biochemistry and Molecular Biology 2016;158:76-81. [DOI: 10.1016/j.jsbmb.2016.01.007] [PMID: ] - DOI - PubMed
    1. Harrington J, Perumal N, Al Mahmud A, Baqui A, Roth DE. Vitamin D and fetal-neonatal calcium homeostasis: findings from a randomized controlled trial of high-dose antenatal vitamin D supplementation. Pediatric Research 2014;76(3):302-9. [DOI: 10.1038/pr.2014.83Abstract] [PMID: ] - DOI - PubMed
    1. Perumal N, Al Mahmud A, Baqui A, Raqib R, Roth D. Effect of high-dose vitamin D supplementation on blood pressure during the third trimester of pregnancy: a randomized controlled trial in Bangladesh. American Journal of Epidemiology 2012;176(1):80.
Rasmussen 2015 {published data only}
    1. Rasmussen GB, Mosekilde L, Sikjaer T, Vestergaard P, Heickendorff L, Uldbjerg N, et al. Effects of high dose vitamin D supplementation on bone metabolism in pregnant women with hypovitaminosis D - a randomized controlled trial. In: Journal of Bone and Mineral Research. Conference: 2015 Annual Meeting of the American Society for Bone and Mineral Research, ASBMR 2015. United States. Vol. 30. 2015.
Roberfroid 2012 {published data only}
    1. Roberfroid D, Huybregts L, Lanou H, Ouedraogo L, Henry MC, Meda N, et al, MISAME study group. Impact of prenatal multiple micronutrients on survival and growth during infancy: a randomized controlled trial. American Journal of Clinical Nutrition 2012;95(4):916-24. [DOI: 10.3945/ajcn.111.029033] [PMID: ] - DOI - PubMed
Roberts 1981 {published data only}
    1. Roberts CC, Chan GM, Folland D, Rayburn C, Jackson R. Adequate bone mineralization in breast-fed infants. Journal of Pediatrics 1981;99(2):192-6. [DOI: 10.1016/s0022-3476(81)80448-9] [PMID: ] - DOI - PubMed
Rosendahl 2017 {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 and Metabolism 2019;104(11):5483-98. [DOI: 10.1210/jc.2019-00630] [PMID: ] - DOI - PubMed
    1. Hauta-Alus HH, Kajantie E, Holmlund-Suila EM, Rosendahl J, Valkama SM, Enlund-Cerullo M, et al. High pregnancy, cord blood, and infant vitamin D concentrations may predict slower infant growth. Journal of Clinical Endocrinology & Metabolism 2019;104(2):397-407. [DOI: 10.1210/jc.2018-00602] [PMID: ] - DOI - PubMed
    1. Helve O, Viljakainen H, Holmlund-Suila E, Rosendahl J, Hauta-alus 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] [PMID: ] - DOI - PMC - PubMed
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    1. NCT04302987. Vitamin D intervention in infants - 6 years follow-up (VIDI2). clinicaltrialsgov/show/NCT04302987 (first received 10 March 2020).
Rostami 2018 {published data only}
    1. Rostami M, Tehrani FR, Simbar M, Bidhendi Yarandi R, Minooee S, Hollis BW, et al. Effectiveness of prenatal vitamin D deficiency screening and treatment program: a stratified randomized field trial. Journal of Clinical Endocrinology & Metabolism 2018;103(8):2936-48. [DOI: 10.1210/jc.2018-00109] [PMID: ] - DOI - PubMed
Saadi 2009 {published data only}
    1. Saadi HF, Dawodu A, Afandi B, Zayed R, Benedict S, Nagelkerke N, et al. Effect of combined maternal and infant vitamin D supplementation on vitamin D status of exclusively breastfed infants. Maternal & Child Nutrition 2009;5(1):25-32. [DOI: 10.1111/j.1740-8709.2008.00145.x] [PMID: ] - DOI - PMC - PubMed
Salas 2018 {published data only}
    1. Salas AA, Woodfin T, Phillips V, Peralta-Carcelen M, Carlo WA, Ambalavanan N. Dose-desponse effects of early vitamin D supplementation on neurodevelopmental and respiratory outcomes of extremely preterm infants at 2 years of age: a randomized trial. Neonatology 2018;113(3):256-62. [DOI: 10.1159/000484399] [PMID: ] - DOI - PMC - PubMed
Savino 2011 {published data only}
    1. Savino F, Viola S, Tarasco V, Lupica MM, Castagno E, Oggero R, et al. Bone mineral status in breast-fed infants: influence of vitamin D supplementation. European Journal of Clinical Nutrition 2011;65(3):335-9. [DOI: 10.1038/ejcn.2010.274] [PMID: ] - DOI - PubMed
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
Siafarikas 2011 {published data only}
    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
Terashita 2017 {published data only}
    1. Terashita S, Nakamura T, Igarashi N. Longitudinal study on the effectiveness of vitamin D supplements in exclusively breast-fed infants. Clinical Pediatric Endocrinology 2017;26(4):215-22. [DOI: 10.1297/cpe.26.215] [PMID: ] - DOI - PMC - PubMed
Tomimoto 2018 {published data only}
    1. Tomimoto K. A study of vitamin D supplementation in breast fed infant with vitamin D deficiency [ビタミンD欠乏状態にある母乳栄養児における 適切なビタミンD補充の検討 ]. Journal of the Japan Pediatric Society 2018;122(11):1683-91.
Wagner 2013 {published data only}
    1. Wagner CL, Howard CR. Maternal vitamin D supplementation (vitD-S) during lactation: results of a two-site RCT. Breastfeeding Medicine 2013;8:S-2.
    1. Wagner CL, McNeil R, Hamilton SA, Winkler J, Rodriguez Cook C, Warner G, et al. A randomized trial of vitamin D supplementation in 2 community health center networks in South Carolina. American Journal of Obstetrics and Gynecology 2013;208(2):137.e1-.e13. [DOI: 10.1016/j.ajog.2012.10.888] [PMID: ] - DOI - PMC - PubMed
Zamora 1999 {published data only}
    1. Zamora SA, Rizzoli R, Belli DC, Slosman DO, Bonjour JP. Vitamin D supplementation during infancy is associated with higher bone mineral mass in prepubertal girls. Journal of Clinical Endocrinology and Metabolism 1999;84(12):4541-4. [DOI: 10.1210/jcem.84.12.6183] [PMID: ] - DOI - PubMed
Ziegler 2014 {published data only}
    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. [PMID: ] - PMC - PubMed
    1. Ziegler EE, Nelson SE, Jeter JM. Iron stores of breastfed infants during the first year of life. Nutrients 2014;6(5):2023-34. [DOI: 10.3390/nu6052023] [PMID: ] - DOI - PMC - PubMed
    1. Ziegler EE, Nelson SE, Jeter JM. Vitamin D supplementation of breastfed infants: a randomized dose-response trial. Pediatric Research 2014;76:177-83. [DOI: 10.1038/pr.2014.76] [PMID: ] - DOI - PMC - PubMed

References to studies awaiting assessment

Kim 2010 {published data only}
    1. Kim MJ, Na B, No SJ, Han HS, Jeong EH, Lee W, et al. Nutritional status of vitamin D and the effect of vitamin D supplementation in Korean breast-fed infants. Journal of Korean Medical Science 2010;25(1):83-9. [DOI: 10.3346/jkms.2010.25.1.83] [PMID: ] - DOI - PMC - PubMed
Wagner 2018 {published data only}
    1. Wagner C, Newton DA, Baatz JE. Maternal vitamin D (VitD) status affects hepatitis B vaccine (HBV) response in breastfeeding infants. In: Breastfeeding Medicine.Conference: 19th International Society for Research in Human Milk and Lactation conference, ISRHML Japan. Vol. 13. 2018:A-12. [CENTRAL: CN-01669515]

References to ongoing studies

ACTRN12614000334606 {published data only}
    1. ACTRN12614000334606. 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 [Can vitamin D supplementation in infants prevent food allergy in the first year of life? The VITALITY Trial]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366006&isRe... (first received 20 March 2014).
    1. Allen KJ, Panjari M, Koplin JJ, Ponsonby AL, 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
ACTRN12615000642583 {published data only}
    1. ACTRN12615000642583. Infants of vitamin D deficient mothers - trial comparing pentavite and vitamin D3 supplement - effect on vitamin D level at 6 weeks [Infants of vitamin D deficient mothers - trial comparing 2 supplement options with vitamin D levels repeated at 6 weeks]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362437 (first received 24 April 2012).
ACTRN12618001992291 {unpublished data only}
    1. ACTRN12618001992291. The Vaccination Infant Supplementation (VISS) Study - assessing the effect of vitamin D and probiotic supplementation around vaccination on infant's temperature and sleep pattern [Randomised placebo-controlled trial investigating the effect of 8 weeks supplementation with probiotics and vitamin D around routine childhood immunisation on infant's ear temperature, growth, and sleeping pattern in 4-24 month-old infants.]. anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376526&isReview... (first received 5 December 2018).
ChiCTR1800020179 {unpublished data only}
    1. ChiCTR1800020179. Study for vitamins and fatty acids status of breast milk and effects of related supplementation during lactation on the health of mothers and infants: a randomized clinical trial [Study for vitamins and fatty acids status of breast milk and effects of related supplementation during lactation on the breast milk composition and the health of mothers and infants: a randomized clinical trial]. www.chictr.org.cn/showprojen.aspx?proj=33888 (first received 19 December 2018).

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