TY - JOUR
T1 - Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial)
T2 - Study protocol for a randomized controlled trial
AU - Roth, Daniel E.
AU - Gernand, Alison D.
AU - Morris, Shaun K.
AU - Pezzack, Brendon
AU - Islam, M. Munirul
AU - Dimitris, Michelle C.
AU - Shanta, Shaila S.
AU - Zlotkin, Stanley H.
AU - Willan, Andrew R.
AU - Ahmed, Tahmeed
AU - Shah, Prakesh S.
AU - Murphy, Kellie E.
AU - Weksberg, Rosanna
AU - Choufani, Sanaa
AU - Shah, Rashed
AU - Al Mahmud, Abdullah
N1 - Funding Information:
We thank the following individuals for their contributions to the design or development of the study procedures and/or trial implementation: Eszter Papp, Lisa Pell, Ashley Motran, Thulasi Thiruchselvam, Jo-Anna Baxter, Hayley Craig-Barnes, Michael Leadley, Pilar Zanoni, Farhana Keya, Tahmid Kashem Qazi, Sadeq-ur Rahman, Kazi Taib Mamun, Frank Martinuzzi. We also thank Dr. Ishrat Jahan, Director of MCHTI, and Kazi Moksedur Rahman, Executive Director of Shimantik (Bangladesh). MDIG Trial Steering Committee (TSC): Tahmeed Ahmed, Alison Gernand, David Hamer (external member), M. Munirul Islam, Abdullah Al Mahmud (site principle investigator [PE]), Shaun Morris, Kellie Murphy, Daniel Roth (PI), Rashed Shah, Prakesh Shah, Rosanna Weksberg, Andrew Willan, and Stanley Zlotkin. The trial is funded by the Bill and Melinda Gates Foundation (BMGF, OPP1066764). The funder was not involved in the writing of the manuscript or the decision to submit the manuscript for publication. ADG’s research is supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (NIH) under BIRCWH award number K12HD055882, Career Development Program in Women’s Health Research at Penn State. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Funding Information:
The Maternal Vitamin D for Infant Growth (MDIG) trial is randomized, placebo-controlled, dose-ranging trial of maternal vitamin D supplementation during pregnancy and lactation to improve infant linear growth in Dhaka, Bangladesh (ClinicalTrials.gov identifier NCT01924013). A detailed trial protocol was developed in accordance with the SPIRIT guidelines [34] through a collaboration between the International Centre for Diarrhoeal Disease Research (ICDDR,B; Dhaka, Bangladesh) and the Hospital for Sick Children (Toronto, ON, Canada) and with funding from the Bill and Melinda Gates Foundation through its Achieving Healthy Growth platform (http://gcgh.grandchallenges.org/grantopportunities/ pages/healthygrowth.aspx).
Publisher Copyright:
© Roth et al. 2015.
PY - 2015/7/14
Y1 - 2015/7/14
N2 - 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.
AB - 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.
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U2 - 10.1186/s13063-015-0825-8
DO - 10.1186/s13063-015-0825-8
M3 - Article
C2 - 26169781
AN - SCOPUS:84936952961
SN - 1745-6215
VL - 16
JO - Trials
JF - Trials
IS - 1
M1 - 300
ER -