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Clinical Trials/NCT00197743
NCT00197743
Completed
Phase 3

Trial of Vitamins in HIV Progression and Transmission

Harvard School of Public Health (HSPH)1 site in 1 country1,085 target enrollmentApril 1995

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Harvard School of Public Health (HSPH)
Enrollment
1085
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
15 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 1995
End Date
August 2003
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Harvard School of Public Health (HSPH)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (1)

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