Trial of Vitamins in HIV Progression and Transmission

Phase 3

Completed

• Conditions: HIV Infections; Disease Transmission, Vertical
• Interventions: Dietary Supplement: Vitamin A + Beta Carotene; Dietary Supplement: Multivitamins; Other: Placebo

• Registration Number: NCT00197743
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief Summary

This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant women in Tanzania would slow disease progression and enhance their overall health.

Detailed Description

In this study, we sought to examine whether the administration of multivitamins excluding vitamin A, multivitamins including vitamin A, or vitamin A alone would reduce the risk of perinatal transmission of HIV and slow the rate of disease progression in a group of pregnant HIV infected women. We also examined the efficacy of the supplements on pregnancy outcomes, and risks of maternal and child morbidity and wasting.

Study Timeline

• Study Start: 1995-04
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1085

Inclusion Criteria

• HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation:

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin A	Vitamin A + Beta Carotene	Vitamin A + Beta Carotene
Multivitamins	Multivitamins	Vitamins B, C, and E
Vitamin A + Multivitamins	Vitamin A + Beta Carotene	Vitamin A + Beta Carotene, Vitamins B, C, and E
Vitamin A + Multivitamins	Multivitamins	Vitamin A + Beta Carotene, Vitamins B, C, and E
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
To examine the effect of multivitamin and/or Vitamin A supplements on the risk of perinatal transmission of HIV and rate of HIV disease progression	until the end of follow-up in August, 2003

Secondary Outcome Measures

Name	Time	Method
To examine the effect of multivitamin and/or Vitamin A supplements on child and maternal morbidity, child growth and child mortality	until the end of follow-up in August 2003

Trial Locations

Locations (1)

Harvard School of Public Health; 🇺🇸 Boston, Massachusetts, United States