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LL-37

Cathelicidin, hCAP-18, FALL-39, CAP-18

Quick Stats
Studies 2230
Trials 95
Completed PHASE2 INTERVENTIONAL NCT01126528

Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

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.

Interventions

Name: Vitamin D3
Type: DIETARY_SUPPLEMENT
Description: 35,000 IU per week, started at 26-29 weeks gestation, until delivery.
Name: Placebo control
Type: DIETARY_SUPPLEMENT
Description: Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.

Primary Outcomes

Measure: Serum 25-hydroxyvitamin D concentration
TimeFrame: Maternal: during 3rd trimester; Neonatal (cord blood)
Description: Biomarker of vitamin D status.

Trial Information

NCT ID

NCT01126528

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last Updated

December 15, 2025