Vitamin A is essential for normal immune function and has shown promise for treatment of different infectious diseases in children. The purpose of the project is to determine whether periodic, oral vitamin A supplementation reduces morbidity and mortality for HIV-infected children in sub-Saharan Africa. The goals of the project are being met through a randomized, double-masked, controlled clinical trial of oral vitamin A supplementation, 60 mg retinol equivalent, every three months for HIV-infected children from 12 to 36 months of age. The project is collaboration between Makerere University and the Johns Hopkins University at the Mulago Hospitals in Kampala, Uganda. The project has involved HIV screening of 23,439 women, identification of 3,751 HIV-infected women, and HIV screening of 1241 infants. The project has enrolled 300 HIV-infected children and is in-progress, and children are scheduled to reach 36 months of age by January 2002. Interim analysis shows that groups appear to be similar at baseline (with different characteristics measured at different ages). The application notes a trend in possible mortality benefit to the children receiving vitamin A. The study is being reviewed annually by a data and safety monitoring committee. In this competing continuation application, it is proposed to complete the clinical trial, laboratory studies, and data analysis over the next 3 years. If vitamin A supplementation is shown to reduce morbidity and mortality for HIV-infected children, this would be an appropriate, low-cost (8 cents for capsules per year), safe, and widely applicable intervention to increase survival for HIV-infected children in developing countries.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD030042-08
Application #
6526969
Study Section
Special Emphasis Panel (ZRG1-AARR-6 (01))
Program Officer
Nugent, Robert
Project Start
1995-02-15
Project End
2003-07-31
Budget Start
2002-08-01
Budget End
2003-07-31
Support Year
8
Fiscal Year
2002
Total Cost
$391,494
Indirect Cost
Name
Johns Hopkins University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Ray, Amanda; Ndugwa, Christopher; Mmirot, Francis et al. (2007) Soluble transferrin receptor as an indicator of iron deficiency in HIV-infected infants. Ann Trop Paediatr 27:11-6
Dancheck, Barbara; Nussenblatt, Veronique; Ricks, Michelle O et al. (2005) Breast milk retinol concentrations are not associated with systemic inflammation among breast-feeding women in Malawi. J Nutr 135:223-6
Dancheck, Barbara; Nussenblatt, Veronique; Kumwenda, Newton et al. (2005) Status of carotenoids, vitamin A, and vitamin E in the mother-infant dyad and anthropometric status of infants in Malawi. J Health Popul Nutr 23:343-50
Semba, Richard D (2003) The ocular complications of smallpox and smallpox immunization. Arch Ophthalmol 121:715-9