Trial | NCT00197743  Report issue

Official Title

Trial of Vitamins in HIV Progression and Transmission

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1085
This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant women in Tanzania would slow disease progression and enhance their overall health.
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 Started
Apr 30
1995
Primary Completion
Aug 31
2003
Study Completion
Aug 31
2003
Last Update
Nov 11
2010
Estimate

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

Other Placebo

Placebo pill

Vitamin A Active Comparator

Vitamin A + Beta Carotene

Multivitamins Active Comparator

Vitamins B, C, and E

Vitamin A + Multivitamins Active Comparator

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

Placebo Placebo Comparator

Placebo

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

-
No Results Posted