Trial of Vitamins Among Children of HIV-infected Women

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197730
First received: September 12, 2005
Last updated: August 20, 2009
Last verified: August 2009

September 12, 2005
August 20, 2009
June 2004
May 2008   (final data collection date for primary outcome measure)
All-cause mortality and diarrheal morbidity [ Time Frame: age 6 weeks to age 24 months ] [ Designated as safety issue: No ]
Child mortality and diarrheal morbidity by 24 months
Complete list of historical versions of study NCT00197730 on ClinicalTrials.gov Archive Site
Child growth faltering, lower respiratory infections, HIV breastfeeding transmission, and maternal HIV disease progression in relation to breastfeeding [ Time Frame: age 6 weeks to 24 months post partum ] [ Designated as safety issue: Yes ]
Growth faltering and HIV transmission through breastfeeding
Not Provided
Not Provided
 
Trial of Vitamins Among Children of HIV-infected Women
Trial of Vitamins Among Children of HIV-infected Women

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Pregnancy Complications
  • 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
  • Experimental: Multivitamins
    Vitamin E, Vitamin C, and Vitamin B complex
    Intervention: Drug: Multivitamins - vitamins B complex, C and E
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2387
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria: Singleton, live born infants born to HIV-infected women Exclusion Criteria: Infants with multiple congenital abnormalities

Both
6 Weeks to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00197730
HD43688
Yes
Wafaie Fawzi, Harvard School of Public Health
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Principal Investigator: Wafaie W Fawzi, MD, DrPH Harvard School of Public Health
Harvard School of Public Health
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP