Trial of Vitamins Among Children of HIV-infected Women
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.
Investigators
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)