NCT00197743

Trial of Vitamins in HIV Progression and Transmission

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,085 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Disease Transmission, Vertical

Interventions

Type	Name	Description
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

Timeline

• Start date: 1995-04-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2005-09-20
• Last updated: 2010-11-11

Locations

1 site across 1 country: United States