Trial of Vitamins in HIV Progression and Transmission

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: Disease Transmission, Vertical; HIV Infections

Treatments: Other: Placebo; Dietary Supplement: Multivitamins; Dietary Supplement: Vitamin A + Beta Carotene

Study type: Interventional

Funder types: Other

Identifiers

NCT00197743

HD32257

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,085 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,085 participants in 4 patient groups, including a placebo group

Vitamin A

Active Comparator group

Description:

Vitamin A + Beta Carotene

Treatment:

Dietary Supplement: Vitamin A + Beta Carotene

Multivitamins

Active Comparator group

Description:

Vitamins B, C, and E

Treatment:

Dietary Supplement: Multivitamins

Vitamin A + Multivitamins

Active Comparator group

Description:

Vitamin A + Beta Carotene, Vitamins B, C, and E

Treatment:

Dietary Supplement: Multivitamins

Dietary Supplement: Vitamin A + Beta Carotene

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo