Trial of Vitamins in HIV Progression and Transmission

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Completed

CT.gov ID

NCT00197743

Collaborator

Muhimbili University of Health and Allied Sciences (Other)

1,085

Enrollment

Location

Arms

100

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Disease Transmission, Vertical	Dietary Supplement: Vitamin A + Beta Carotene Dietary Supplement: Multivitamins Other: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

1085 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Trial of Vitamins in HIV Progression and Transmission

Study Start Date :

Apr 1, 1995

Actual Primary Completion Date :

Aug 1, 2003

Actual Study Completion Date :

Aug 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamin A Vitamin A + Beta Carotene	Dietary Supplement: Vitamin A + Beta Carotene one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
Active Comparator: Multivitamins Vitamins B, C, and E	Dietary Supplement: Multivitamins one daily oral dose of 20 mg thiamine (vitamin B-1), 20 mg riboflavin (vitamin B-2), 25 mg vitamin B-6, 100 mg niacin, 50 ug cobalamin (vitamin B-12), 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid
Active Comparator: Vitamin A + Multivitamins Vitamin A + Beta Carotene, Vitamins B, C, and E	Dietary Supplement: Vitamin A + Beta Carotene one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A Dietary Supplement: Multivitamins one daily oral dose of 20 mg thiamine (vitamin B-1), 20 mg riboflavin (vitamin B-2), 25 mg vitamin B-6, 100 mg niacin, 50 ug cobalamin (vitamin B-12), 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid
Placebo Comparator: Placebo Placebo	Other: Placebo Placebo pill

Outcome Measures

Primary Outcome Measures

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

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]