Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial (AViDD-2)
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.
|Pregnancy||Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo control||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- Serum 25-hydroxyvitamin D concentration [ Time Frame: Maternal: during 3rd trimester; Neonatal (cord blood) ]Biomarker of vitamin D status.
- Serum calcium concentration [ Time Frame: Maternal:3rd trimester; Cord blood. ]
- Urine Ca:Cr ration [ Time Frame: Maternal- 3rd trimester ]
- Neonatal immune function [ Time Frame: Cord blood ]Selected markers of innate and adaptive immunity.
- Infant growth [ Time Frame: Postnatal observational follow-up phase ]Infant growth parameters during postnatal follow-up, up to 12 months of age
- Infant and maternal postnatal vitamin D status [ Time Frame: Postnatal observational follow-up phase ]
- Neonatal serum calcium [ Time Frame: 1st week postnatal ]Infant serum calcium during the first week postnatal.
|Study Start Date:||August 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D3
Vitamin D3 (cholecalciferol)
Dietary Supplement: Vitamin D3
35,000 IU per week, started at 26-29 weeks gestation, until delivery.
Other Name: Cholecalciferol; Vigantol Oil
Placebo Comparator: Control
Placebo control group
Dietary Supplement: Placebo control
Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126528
|International Centre for Diarrheal Disease Research, Bangladesh (ICDDR,B)|
|Principal Investigator:||Abdullah Baqui, MBBS||JHSPH; ICDDR,B|
|Principal Investigator:||Daniel Roth, MD||Johns Hopkins Bloomberg School of Public Health|
|Principal Investigator:||Rubhana Raqib, PhD||International Centre for Diarrhoeal Disease Research, Bangladesh|