Trial of Vitamins Among Children of HIV-infected Women

Phase 3

Completed

• Conditions: HIV Infections; Pregnancy Complications
• Interventions: Drug: Placebo; Drug: Multivitamins - vitamins B complex, C and E

• Registration Number: NCT00197730
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2387

Inclusion Criteria

Singleton, live born infants born to HIV-infected women

Exclusion Criteria

Infants with multiple congenital abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Multivitamins	Multivitamins - vitamins B complex, C and E	Vitamin E, Vitamin C, and Vitamin B complex

Primary Outcome Measures

Name	Time	Method
All-cause mortality and diarrheal morbidity	age 6 weeks to age 24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Muhimbili University of Health and Allied Sciences; 🇹🇿 Dar es Salaam, Tanzania