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Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial

NCT01126528 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2012-08-17

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

35,000 IU per week, started at 26-29 weeks gestation, until delivery.

DIETARY_SUPPLEMENT

Placebo control

Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Abdullah Baqui, MBBS · JHSPH; ICDDR,B

  • Daniel Roth, MD · Johns Hopkins Bloomberg School of Public Health

  • Rubhana Raqib, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-05-31
Completion
2012-05-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01126528 on ClinicalTrials.gov