Trial of Vitamins in HIV Progression and Transmission

Study Overview
=================
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.

Official Title
-----------------
Trial of Vitamins in HIV Progression and Transmission

Conditions
-----------------
HIV Infections, Disease Transmission, Vertical

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin A + Beta Carotene
* Dietary Supplement: Multivitamins
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation: Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin A<br>Vitamin A + Beta Carotene | Dietary Supplement: Vitamin A + Beta Carotene<br>* one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A<br>|
| Active Comparator: Multivitamins<br>Vitamins B, C, and E | Dietary Supplement: Multivitamins<br>* 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<br>|
| Active Comparator: Vitamin A + Multivitamins<br>Vitamin A + Beta Carotene, Vitamins B, C, and E | Dietary Supplement: Vitamin A + Beta Carotene<br>* one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A<br>Dietary Supplement: Multivitamins<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo pill<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Multivitamins, Pregnancy outcomes, Tanzania, Women