At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 2,300 enrolled

Drug / intervention

Vitamin D3 (cholecalciferol) +1 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/NCT02305927

NCT02305927Phase 3Completed

Compare CT.gov

Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health

Wafaie Fawzi·interventional·Posted Dec 3, 2014·Updated Apr 24, 2020

In Brief

A Phase 3 clinical trial evaluating Vitamin D3 (cholecalciferol) and Placebo for HIV. Completed, enrolled 2,300 participants across 1 site.

Detailed Summary

The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol) supplementation on maternal HIV progression, small-for-gestational age infants, and infant stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving highly active antiretroviral therapy (HAART).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV

CountriesTanzania

CollaboratorsManagement and Development for Health (MDH)

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

First PostedDec 2014

Enrollment StartJun 2015

Primary CompletionSep 2019

TodayJul 2026

First PostedDec 3, 2014

Enrollment StartJun 15, 2015

Primary CompletionSep 18, 2019

TodayJul 2, 2026

Enrollment to primary: 4.3 yearsPosted 11.6 years ago

Interventions

Vitamin D3 (cholecalciferol)dietary

Supplements containing 3,000 IU vitamin D3 taken orally once per day by the mother starting from the second trimester until 12 months postpartum

Placeboother

Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum