Journal Article

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

Weksberg, Rosanna, Islam, M. Munirul, Gernand, Alison D., Choufani, Sanaa, Shanta, Shaila S., Shah, Rashed, Morris, Shaun K., Ahmed, Tahmeed, Pezzack, Brendon, Dimitris, Michelle C., Zlotkin, Stanley H., Roth, Daniel E., Al Mahmud, Abdullah, Shah, Prakesh S., Willan, Andrew R., Murphy, Kellie E.

2015

Overview

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 D 3 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 D 3 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

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Administration, Oral / Age / Age Factors / Alfacalcidol / Babies / Bangladesh - epidemiology / Biomedicine / Body Height / Breastfeeding & lactation / Calcifediol / Child Development / Child, Preschool / Childbirth & labor / Cholecalciferol - administration & dosage / Clinical Protocols / Clinical trials / Developing Countries / Dietary Supplements / Double-Blind Method / Drug Administration Schedule / Enrollments / Epigenetics / Female / Growth / Growth Disorders - epidemiology / Growth Disorders - physiopathology / Growth Disorders - prevention & control / Health aspects / Health Sciences / Humans / Infant / Infant Nutritional Physiological Phenomena / Infant, Newborn / Infants / Lactation / Male / Maternal & child health / Maternal Nutritional Physiological Phenomena / Measurement / Medicine / Medicine & Public Health / Metabolism / Mortality / Nutritional Status / Observational studies / Physiological aspects / Pregnancy / Pregnant women / Prevalence / Public health / Research Design / Rickets / Statistics for Life Sciences / Study Protocol / Time Factors / Treatment Outcome / Vitamin D / Vitamin deficiency / Women / Womens health