The purpose of the study is to determine whether vitamin A supplementation can enhance immunity and reduce morbidity and mortality for HIV-1 infected children. We propose to conduct a randomized, placebo- controlled clinical trial of vitamin A supplementation for HIV-infected children in Rwanda, Africa. Our preliminary studies show that vitamin A deficiency is relatively common in HIV-infected children and adults, that vitamin A deficiency is associated with increased mortality during HIV-I infection, and that high vitamin A intake is associated with slower progression to AIDS. Vitamin A is an essential micronutrient for mucosal, humoral, and cellular immunity, and vitamin A deficiency leads to increased susceptibility to infection. Vitamin A is known to restore mucosal integrity, enhance specific IgG responses, increase circulating CD4 T-cells, reduce anemia, and increase overall resistance to infection. In the last eight years, clinical trials have shown that vitamin A supplementation reduces revere infectious disease morbidity and mortality in children. HIV/AIDS is emerging as a leading cause of childhood mortality, and in developing countries there is no appropriate strategy to increase survival in HIV-1 infected children. The goal will be met through a clinical trial which utilizes infrastructure established during NIH-sponsored HIV/AIDS research in Butare, Rwanda.
The specific aims are to determine if vitamin A supplementation will reduce morbidity and mortality, enhance immunity, increase hematopoiesis, and reduce HIV p24 antigenemia in HIV-1 infected children. If vitamin A supplementation is shown to reduce morbidity and mortality for HIV-infected children, this may be an appropriate, low-cost (8 cents per year, compared to $3000 for zidovudine) strategy to increase survival for HIV-infected children. Vitamin A supplementation has been shown to be one of the most cost- effective interventions to reduce mortality in children, and it remains to be determined whether it will be of health benefit to the growing numbers of 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 #
5R01HD030042-05
Application #
2872830
Study Section
AIDS and Related Research Study Section 2 (ARRB)
Program Officer
Nugent, Robert
Project Start
1995-02-15
Project End
2000-08-20
Budget Start
1999-02-01
Budget End
2000-08-20
Support Year
5
Fiscal Year
1999
Total Cost
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