CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 75 enrolled
Drug / intervention
Vitamin D3 +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00938600
NCT00938600Phase 1Completed
CompareCT.gov

Antenatal Vitamin D Supplementation to Improve Neonatal Health Outcomes in Dhaka, Bangladesh: Preliminary Dose-finding and Safety Study

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Jul 14, 2009·Updated Aug 17, 2012

In Brief

A Phase 1 clinical trial evaluating Vitamin D3 for Pregnancy and 2 related conditions. Completed, enrolled 75 participants across 1 site.

Detailed Summary

This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant women of reproductive age in Bangladesh. The primary objective of the study is to identify a dose of vitamin D3 that can safely be administered during pregnancy to improve the vitamin D status of the mother and infant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Nutritional Status, Vitamin D
CountriesBangladesh
CollaboratorsJohns Hopkins University

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.0 years ago

Interventions

Vitamin D3dietary

Vitamin D3 oral liquid 70,000 IU once

Vitamin D3dietary

Vitamin D3 oral liquid 70,000 IU as loading dose, then 35,000 IU weekly thereafter for 10 weeks (non-pregnant) or until delivery (pregnant)

Vitamin D3dietary

Vitamin D3 14,000 IU per week by mouth, starting at 27-30 weeks gestation and continued until delivery.