Trial of Vitamins Among Children of HIV-infected Women

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Completed

CT.gov ID

NCT00197730

Collaborator

Muhimbili University of Health and Allied Sciences (Other)

2,387

Enrollment

Location

Arms

Duration (Months)

50.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Pregnancy Complications	Drug: Multivitamins - vitamins B complex, C and E Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

2387 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Trial of Vitamins Among Children of HIV-infected Women

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multivitamins Vitamin E, Vitamin C, and Vitamin B complex	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
Placebo Comparator: Placebo Placebo	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

Arm

Intervention/Treatment

Experimental: Multivitamins

Vitamin E, Vitamin C, and Vitamin B complex

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

Placebo Comparator: Placebo

Placebo

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

Outcome Measures

Primary Outcome Measures

All-cause mortality and diarrheal morbidity [age 6 weeks to age 24 months]

Secondary Outcome Measures

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]