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Clinical Trials/NCT00197730
NCT00197730
Completed
Phase 3

Trial of Vitamins Among Children of HIV-infected Women

Harvard School of Public Health (HSPH)1 site in 1 country2,387 target enrollmentJune 2004

Overview

Phase
Phase 3
Intervention
Multivitamins - vitamins B complex, C and E
Conditions
HIV Infections
Sponsor
Harvard School of Public Health (HSPH)
Enrollment
2387
Locations
1
Primary Endpoint
All-cause mortality and diarrheal morbidity
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to examine the effects of multivitamin (B, C, E) supplementation on reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.

Detailed Description

An increasing body of evidence supports the efficacy of single and, more recently, multiple micronutrient supplementation in reducing morbidity and mortality in susceptible populations. For example, we recently completed a multiple micronutrient supplementation trial in HIV-positive Tanzanian women that showed a significant reduction in pre-term birth, fetal loss, and low birthweight. In children, we and others have also demonstrated the beneficial effects of vitamin A supplementation in reducing diarrheal disease and mortality. Our next priority is to evaluate the efficacy of multiple micronutrient supplementation in susceptible children. Children born to HIV-infected women are at risk of multiple micronutrient deficiencies due to poor dietary intake, malabsorption, and increased metabolic needs. In addition, these children, if HIV-infected themselves, are at significantly higher risk of death due to infectious illnesses compared to their non-infected peers. In this study, we propose to study the efficacy of micronutrient supplementation in reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
May 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Harvard School of Public Health (HSPH)

Eligibility Criteria

Inclusion Criteria

  • Singleton, live born infants born to HIV-infected women

Exclusion Criteria

  • Infants with multiple congenital abnormalities

Arms & Interventions

Multivitamins

Vitamin E, Vitamin C, and Vitamin B complex

Intervention: Multivitamins - vitamins B complex, C and E

Placebo

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

All-cause mortality and diarrheal morbidity

Time Frame: age 6 weeks to age 24 months

Secondary Outcomes

  • Child growth faltering, lower respiratory infections, HIV breastfeeding transmission, and maternal HIV disease progression in relation to breastfeeding(age 6 weeks to 24 months post partum)

Study Sites (1)

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