Trial of Vitamins in HIV Progression and Transmission

HIV Infections Clinical Trial

Official title:

Trial of Vitamins in HIV Progression and Transmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197743
• Other study ID #: HD32257
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 9, 2010
• Start date: April 1995
• Est. completion date: August 2003

Study information

• Verified date: November 2010
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1085
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disease Transmission, Vertical
• HIV Infections

Intervention

Dietary Supplement:
• Vitamin A + Beta Carotene
one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
• 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

Other:
• Placebo
Placebo pill

Locations

Country	Name	City	State
United States	Harvard School of Public Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 Imm — View Citation

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 — View Citation

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 T — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No