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Trial of Vitamins Among Children of HIV-infected Women

Trial of Vitamins Among Children of HIV-infected Women

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00197730
Enrollment
2387
Registered
2005-09-20
Start date
2004-06-30
Completion date
2008-05-31
Last updated
2009-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Pregnancy Complications

Keywords

Birth Outcomes, Nutrition, HIV, AIDS, Vitamins, Multivitamins, Maternal and child health outcomes, Tanzania, Africa

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.

Interventions

DRUGMultivitamins - 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

DRUGPlacebo

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

Sponsors

Muhimbili University of Health and Allied Sciences
CollaboratorOTHER
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Weeks to 24 Months
Healthy volunteers
No

Inclusion criteria

Singleton, live born infants born to HIV-infected women

Exclusion criteria

Infants with multiple congenital abnormalities

Design outcomes

Primary

MeasureTime frame
All-cause mortality and diarrheal morbidityage 6 weeks to age 24 months

Secondary

MeasureTime frame
Child growth faltering, lower respiratory infections, HIV breastfeeding transmission, and maternal HIV disease progression in relation to breastfeedingage 6 weeks to 24 months post partum

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026