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Trial of Vitamins in HIV Progression and Transmission

NCT00197743 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1085

Last updated 2010-11-11

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Disease Transmission, Vertical

Interventions

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

OTHER

Placebo

Placebo pill

Sponsors & Collaborators

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Wafaie W Fawzi, MD,DrPh · Harvard School of Public Health (HSPH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-04-30
Primary Completion
2003-08-31
Completion
2003-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00197743 on ClinicalTrials.gov