Trial of Vitamins in HIV Progression and Transmission

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00197743

Enrollment

1085

Registered

2005-09-20

Start date

1995-04-30

Completion date

2003-08-31

Last updated

2010-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Disease Transmission, Vertical

Keywords

HIV, Multivitamins, Pregnancy outcomes, Tanzania, Women

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.

Interventions

DIETARY_SUPPLEMENTVitamin A + Beta Carotene

one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A

DIETARY_SUPPLEMENTMultivitamins

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

OTHERPlacebo

Placebo pill

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026