MedDataX Logo

Trial of Vitamins in HIV Progression and Transmission

NCT ID: NCT00197743

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1085 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-04-30

Study Completion Date

2003-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Disease Transmission, Vertical

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV Multivitamins Pregnancy outcomes Tanzania Women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin A

Vitamin A + Beta Carotene

Group Type ACTIVE_COMPARATOR

Vitamin A + Beta Carotene

Intervention Type DIETARY_SUPPLEMENT

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

Multivitamins

Vitamins B, C, and E

Group Type ACTIVE_COMPARATOR

Multivitamins

Intervention Type 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

Vitamin A + Multivitamins

Vitamin A + Beta Carotene, Vitamins B, C, and E

Group Type ACTIVE_COMPARATOR

Vitamin A + Beta Carotene

Intervention Type DIETARY_SUPPLEMENT

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

Multivitamins

Intervention Type 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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin A + Beta Carotene

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo pill

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Harvard School of Public Health

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wafaie W Fawzi, MD,DrPh

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harvard School of Public Health

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1056/NEJMoa040541.

Reference Type RESULT
PMID: 15229304 (View on PubMed)

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. doi: 10.1097/00002030-200209270-00011.

Reference Type RESULT
PMID: 12351954 (View on PubMed)

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. doi: 10.1097/00126334-200003010-00006.

Reference Type RESULT
PMID: 10839660 (View on PubMed)

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. doi: 10.1016/s0140-6736(98)04197-x.

Reference Type RESULT
PMID: 9605804 (View on PubMed)

Khavari N, Jiang H, Manji K, Msamanga G, Spiegelman D, Fawzi W, Duggan C. Maternal multivitamin supplementation reduces the risk of diarrhoea among HIV-exposed children through age 5 years. Int Health. 2014 Dec;6(4):298-305. doi: 10.1093/inthealth/ihu061. Epub 2014 Aug 30.

Reference Type DERIVED
PMID: 25173342 (View on PubMed)

Natchu UC, Liu E, Duggan C, Msamanga G, Peterson K, Aboud S, Spiegelman D, Fawzi WW. Exclusive breastfeeding reduces risk of mortality in infants up to 6 mo of age born to HIV-positive Tanzanian women. Am J Clin Nutr. 2012 Nov;96(5):1071-8. doi: 10.3945/ajcn.111.024356. Epub 2012 Oct 10.

Reference Type DERIVED
PMID: 23053555 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HD32257

Identifier Type: -

Identifier Source: org_study_id