Pregnancy Clinical Trial
Official title:
The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh
This study is a randomized placebo-controlled trial of oral weekly vitamin D3
(cholecalciferol) supplementation during the third trimester of pregnancy among women in
Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence
that improving vitamin D status among pregnant women in Bangladesh will enhance the
resistance of the infant offspring to infection.
The aims of the study are to assess the effect of supplementation on 1) maternal and infant
vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers
of neonatal immune function.
The primary aims of this study are:
AIM #1 - To assess the effect of weekly antenatal administration of oral vitamin D3 (875
mcg/week = 35,000 IU week ≈ 5,000 IU per day) started in the third trimester (26-29 weeks
gestation) on maternal vitamin D status and fetal-neonatal vitamin D status (cord blood), in
comparison to a placebo control supplement.
AIM #2 - To demonstrate the maternal and fetal safety of weekly maternal antenatal (second
and third-trimester) vitamin D supplementation at a dose of 875 mcg/week by monitoring
maternal serum calcium, urinary calcium excretion, cord blood calcium concentration, and
newborn clinical parameters.
AIM #3 - To measure the effect of antenatal vitamin D supplementation on selected biomarkers
of fetal-neonatal immune function in cord blood: in vitro stimulated cord blood mononuclear
cell (CBMC) LL-37 expression, gene expression related to inflammatory and immunoregulatory
pathways, Th1/Th2 cytokine secretion, and bactericidal properties.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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