Randomized Controlled Trial

. 2015 Jul 14:16:300.

doi: 10.1186/s13063-015-0825-8.

Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial

Daniel E Roth^{1

2}, Alison D Gernand³, Shaun K Morris^{4

5}, Brendon Pezzack^{6

7}, M Munirul Islam⁸, Michelle C Dimitris^{9

10}, Shaila S Shanta¹¹, Stanley H Zlotkin^{12

13}, Andrew R Willan¹⁴, Tahmeed Ahmed¹⁵, Prakesh S Shah^{16

17}, Kellie E Murphy¹⁸, Rosanna Weksberg^{19

20}, Sanaa Choufani²¹, Rashed Shah²², Abdullah Al Mahmud²³

Affiliations

¹ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. daniel.roth@sickkids.ca.
² Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. daniel.roth@sickkids.ca.
³ Department of Nutritional Sciences, Penn State University, 110 Chandlee Laboratory, University Park, PA, USA. adg14@psu.edu.
⁴ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. shaun.morris@sickkids.ca.
⁵ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. shaun.morris@sickkids.ca.
⁶ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. bpezzack@gmail.com.
⁷ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. bpezzack@gmail.com.
⁸ Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research (ICDDR,B), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. mislam@icddrb.org.
⁹ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. michelle.dimitris@sickkids.ca.
¹⁰ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. michelle.dimitris@sickkids.ca.
¹¹ Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research (ICDDR,B), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. shaila.sharmeen@icddrb.org.
¹² Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. stanley.zlotkin@sickkids.ca.
¹³ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. stanley.zlotkin@sickkids.ca.
¹⁴ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. andy@andywillan.com.
¹⁵ Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research (ICDDR,B), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. tahmeed@icddrb.org.
¹⁶ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. pshah@mtsinai.on.ca.
¹⁷ Division of Neonatology, Mt. Sinai Hospital, 600 University Avenue, Toronto, ON, Canada. pshah@mtsinai.on.ca.
¹⁸ Department of Obstetrics and Gynecology, University of Toronto and Mt. Sinai Hospital, 600 University Avenue, Toronto, ON, Canada. kmurphy@mtsinai.on.ca.
¹⁹ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. rweksb@sickkids.ca.
²⁰ Genetics and Genome Biology, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. rweksb@sickkids.ca.
²¹ Genetics and Genome Biology, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. sanaa.choufani@sickkids.ca.
²² Department of Health and Nutrition, Save the Children USA, 2000 L Street NW, Suite 500, Washington, DC, USA. mshah@savechildren.org.
²³ Centre for Child and Adolescent Health, International Centre for Diarrhoeal Disease Research (ICDDR,B), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. mahmud@icddrb.org.

PMID: 26169781
PMCID: PMC4499946
DOI: 10.1186/s13063-015-0825-8

Randomized Controlled Trial

Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial

Daniel E Roth et al. Trials. 2015.

. 2015 Jul 14:16:300.

doi: 10.1186/s13063-015-0825-8.

Authors

Affiliations

¹ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. daniel.roth@sickkids.ca.
² Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. daniel.roth@sickkids.ca.
³ Department of Nutritional Sciences, Penn State University, 110 Chandlee Laboratory, University Park, PA, USA. adg14@psu.edu.
⁴ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. shaun.morris@sickkids.ca.
⁵ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. shaun.morris@sickkids.ca.
⁶ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. bpezzack@gmail.com.
⁷ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. bpezzack@gmail.com.
⁸ Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research (ICDDR,B), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. mislam@icddrb.org.
⁹ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. michelle.dimitris@sickkids.ca.
¹⁰ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. michelle.dimitris@sickkids.ca.
¹¹ Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research (ICDDR,B), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. shaila.sharmeen@icddrb.org.
¹² Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. stanley.zlotkin@sickkids.ca.
¹³ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. stanley.zlotkin@sickkids.ca.
¹⁴ Child Health Evaluative Sciences, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. andy@andywillan.com.
¹⁵ Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research (ICDDR,B), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. tahmeed@icddrb.org.
¹⁶ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. pshah@mtsinai.on.ca.
¹⁷ Division of Neonatology, Mt. Sinai Hospital, 600 University Avenue, Toronto, ON, Canada. pshah@mtsinai.on.ca.
¹⁸ Department of Obstetrics and Gynecology, University of Toronto and Mt. Sinai Hospital, 600 University Avenue, Toronto, ON, Canada. kmurphy@mtsinai.on.ca.
¹⁹ Department of Paediatrics, University of Toronto and the Centre for Global Child Health, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. rweksb@sickkids.ca.
²⁰ Genetics and Genome Biology, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. rweksb@sickkids.ca.
²¹ Genetics and Genome Biology, SickKids Research Institute, Hospital for Sick Children, 686 Bay Street, Toronto, ON, Canada. sanaa.choufani@sickkids.ca.
²² Department of Health and Nutrition, Save the Children USA, 2000 L Street NW, Suite 500, Washington, DC, USA. mshah@savechildren.org.
²³ Centre for Child and Adolescent Health, International Centre for Diarrhoeal Disease Research (ICDDR,B), 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. mahmud@icddrb.org.

PMID: 26169781
PMCID: PMC4499946
DOI: 10.1186/s13063-015-0825-8

Abstract

Background: Vitamin D regulates bone mineral metabolism and skeletal development. Some observational studies have suggested that prenatal vitamin D deficiency increases the risk of adverse pregnancy and/or birth outcomes; however, there is scant evidence from controlled trials, leading the World Health Organization to advise against routine vitamin D supplementation in pregnancy. Importantly, little is known about the effect of maternal vitamin D status on infant linear growth in communities in South Asia where stunting is highly prevalent and maternal-infant vitamin D status is commonly suboptimal.

Methods/design: The Maternal Vitamin D for Infant Growth study is a randomized, placebo-controlled, dose-ranging trial of maternal vitamin D supplementation during pregnancy and lactation in Dhaka, Bangladesh. The primary aims are to estimate (1) the effect of maternal prenatal oral vitamin D3 supplementation (4200 IU/wk, 16,800 IU/wk, or 28,000 IU/wk, administered as weekly doses) versus placebo on infant length at 1 year of age and (2) the effect of maternal postpartum oral vitamin D3 supplementation (28,000 IU/wk) versus placebo on length at 1 year of age among infants born to women who received vitamin D 28,000 IU/wk during pregnancy. Generally healthy pregnant women (n = 1300) in the second trimester (17-24 weeks of gestation) are randomized to one of five parallel arms: placebo 4200 IU/wk, 16,800 IU/wk, or 28,000 IU/wk in the prenatal period and placebo in the postpartum period or 28,000 IU/wk in the prenatal period and 28,000 IU/wk in the postpartum period. Household- and clinic-based follow-up of mother-infant pairs is conducted weekly by trained personnel until 26 weeks postpartum and every 3 months thereafter. The primary trial outcome measure is length for age z-score at 1 year of age. Anthropometric measurements, clinical information, and biological specimens collected at scheduled intervals will enable the assessment of a range of maternal, perinatal, and infant outcomes.

Discussion: The role of vitamin D in maternal and infant health remains unresolved. This trial is expected to contribute unique insights into the effects of improving maternal-infant vitamin D status in a low-income setting where stunting and adverse perinatal outcomes represent significant public health burdens.

Trial registration: ClinicalTrials.gov identifier: NCT01924013. Registered on 13 August 2013.

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Figures

**Fig. 1**
Maternal Vitamin D for Infant Growth (MDIG) trial flow diagram. The allocated intervention in each group is shown as “prenatal intervention; postpartum intervention”

See this image and copyright information in PMC

References

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Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial

Affiliations

Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

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Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

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Medical