Trial of Vitamins in HIV Progression and Transmission

This study has been completed.

First Received: September 13, 2005 Last Updated: January 24, 2007 History of Changes

Sponsors and Collaborators:	Harvard School of Public Health Muhimbili University of Health and Allied Sciences
Information provided by:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00197743

Purpose

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

Condition	Intervention	Phase
HIV Infections Disease Transmission, Vertical	Drug: Multivitamins	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Trial of Vitamins in HIV Progression and Transmission

Resource links provided by NLM:

MedlinePlus related topics: AIDS Dietary Supplements

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	1085
Study Start Date:	April 1995
Estimated Study Completion Date:	August 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197743

Locations

United States, Massachusetts
Harvard School of Public Health
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Harvard School of Public Health

Muhimbili University of Health and Allied Sciences

Investigators

Principal Investigator:

Wafaie W Fawzi, MD,DrPh

Harvard School of Public Health

More Information

No publications provided

Study ID Numbers:	HD32257
Study First Received:	September 13, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00197743 History of Changes
Health Authority:	United States: Institutional Review Board; Tanzania: Institutional Review Board

Keywords provided by Harvard School of Public Health:

HIV
Multivitamins
Pregnancy outcomes
Tanzania
Women

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Vitamins
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Disease Progression
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 03, 2009