Trial of Vitamins in HIV Progression and Transmission - Full Text View

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	Dietary Supplement: Vitamin A + Beta Carotene Dietary Supplement: Multivitamins Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Trial of Vitamins in HIV Progression and Transmission

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: B Vitamins Dietary Supplements HIV/AIDS Vitamin A

Drug Information available for: Retinol Vitamin A palmitate beta carotene

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 [ Time Frame: until the end of follow-up in August, 2003 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	1085
Study Start Date:	April 1995
Study Completion Date:	August 2003
Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vitamin A Vitamin A + Beta Carotene	Dietary Supplement: Vitamin A + Beta Carotene one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
Active Comparator: Multivitamins Vitamins B, C, and E	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
Active Comparator: Vitamin A + Multivitamins Vitamin A + Beta Carotene, Vitamins B, C, and E	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
Placebo Comparator: Placebo Placebo	Other: Placebo Placebo pill

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

Publications:

Fawzi WW, Msamanga GI, Spiegelman D, Wei R, Kapiga S, Villamor E, Mwakagile D, Mugusi F, Hertzmark E, Essex M, Hunter DJ. A randomized trial of multivitamin supplements and HIV disease progression and mortality. N Engl J Med. 2004 Jul 1;351(1):23-32.

Fawzi WW, Msamanga GI, Hunter D, Renjifo B, Antelman G, Bang H, Manji K, Kapiga S, Mwakagile D, Essex M, Spiegelman D. Randomized trial of vitamin supplements in relation to transmission of HIV-1 through breastfeeding and early child mortality. AIDS. 2002 Sep 27;16(14):1935-44.

Fawzi WW, Msamanga G, Hunter D, Urassa E, Renjifo B, Mwakagile D, Hertzmark E, Coley J, Garland M, Kapiga S, Antelman G, Essex M, Spiegelman D. Randomized trial of vitamin supplements in relation to vertical transmission of HIV-1 in Tanzania. J Acquir Immune Defic Syndr. 2000 Mar 1;23(3):246-54.

Fawzi WW, Msamanga GI, Spiegelman D, Urassa EJ, McGrath N, Mwakagile D, Antelman G, Mbise R, Herrera G, Kapiga S, Willett W, Hunter DJ. Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania. Lancet. 1998 May 16;351(9114):1477-82.

Responsible Party:	Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00197743 History of Changes
Other Study ID Numbers:	HD32257
Study First Received:	September 13, 2005
Last Updated:	November 9, 2010
Health Authority:	United States: Institutional Review Board Tanzania: National Institute for Medical Research

Keywords provided by Harvard School of Public Health:

HIV
Multivitamins
Pregnancy outcomes
Tanzania
Women

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Carotenoids
Retinol palmitate

Vitamin A
Vitamins
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 14, 2013