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Completed

NCT Number: NCT00197743

Trial of Vitamins in HIV Progression and Transmission

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Disease Transmission, Vertical Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Vitamin A + Beta Carotene

Dietary Supplement

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

Multivitamins

Dietary Supplement

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

Placebo

Other

Placebo pill

Primary outcomes

  1. 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

    Time frame: until the end of follow-up in August, 2003

Secondary outcomes

  1. To examine the effect of multivitamin and/or Vitamin A supplements on child and maternal morbidity, child growth and child mortality

    Time frame: until the end of follow-up in August 2003

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Important dates

Study start
1995
Primary completion
2003
Study completion
2003
First posted
Sep 20, 2005
Registry last updated
Nov 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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