NCT00197730

Trial of Vitamins Among Children of HIV-infected Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,387 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 6 Weeks – 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Pregnancy Complications

Interventions

Type	Name	Description
DRUG	Multivitamins - vitamins B complex, C and E	Age-appropriate dosages of vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folate, and vitamin B12 administered orally to children aged 6 weeks to 6 months, and two capsules per day for children aged older than 6 months for at least 12 months
DRUG	Placebo	Placebo capsules administered orally once day orally to children aged 6 weeks to 6 months, and twice per day for children aged older than 6 months

Timeline

• Start date: 2004-06-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2005-09-20
• Last updated: 2009-08-21

Locations

1 site across 1 country: Tanzania