At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 59,666 enrolled

Drug / intervention

Vitamin A or Beta-Carotene Supplementsdietary

Likely dose

Vitamin A 7000 µg retinol equivalents weekly or beta-carotene 42 mg weeklyAI-extracted

Key inclusion· 2

✓Married women
✓First pregnancy during the trial period

Key exclusion· 6

✕Previous pregnancy history during trial enrollment
✕Premenarchial girls
✕Previously married women who have moved into study area
✕Single women (never married, widowers)

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

Search/NCT00198822

NCT00198822Phase 3Completed

Compare CT.gov

Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Sep 20, 2005·Updated Mar 7, 2012

In Brief

A Phase 3 clinical trial evaluating Vitamin A or Beta-Carotene Supplements for Vitamin A Deficiency and 2 related conditions. Completed, enrolled 59,666 participants across 3 sites in 2 countries.

Detailed Summary

The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsVitamin A Deficiency, Maternal Mortality, Infant Mortality

CountriesBangladesh, United States

CollaboratorsUnited States Agency for International Development (USAID), Bill and Melinda Gates Foundation, Canadian International Development Agency, The Sight and Life Research Institute, Access Business Group

Timeline

Phase 3CompletedFinished

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2001

First PostedSep 2005

Primary CompletionJan 2007

Study CompletionMar 2008

TodayJul 2026

First PostedSep 20, 2005

Enrollment StartAug 1, 2001

Primary CompletionJan 1, 2007

Study CompletionMar 1, 2008

TodayJul 2, 2026

Enrollment to primary: 5.4 yearsPosted 20.8 years ago

Interventions

Vitamin A or Beta-Carotene Supplementsdietary

weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy