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Nutritional Support for Africans Starting Antiretroviral Therapy (NUSTART)

Nutritional Support for Africans Starting Antiretroviral Therapy (NUSTART) is a two-center (Lusaka, Zambia and Mwanza, Tanzania) randomized controlled trial funded by the European and Developing Countries Clinical Trials Partnership and sponsored by the London School of Hygiene & Tropical Medicine. Vanderbilt Institute for Global Health Associate Director, Douglas C. Heimburger, M.D., M.S., and John R. Koethe, M.D., serve as a co-investigators working with researchers from universities in Zambia, Tanzania, London, Denmark, and Ethiopia.

The project will address mortality resulting from malnutrition in Africans after starting combination antiretroviral therapy (cART) for HIV/AIDS by investigating whether nutritional supplementation can improve survival. The specific aim of the trial will be to determine whether the provision of micronutrients and bulk minerals to African adults in the first few weeks after referral for cART can decrease the high mortality seen among these patients. Secondary trial objectives are designed to understand the impact of the intervention on the recovery of appetite, hospitalization rates, CD4 count, body mass index, lean body mass, iron status, grip strength, HIV viral load, and adherence to cART. The NUSTART trial was designed as a follow-on intervention after the results of an observational study conducted by Dr. Heimburger and colleagues at the Centre for Infectious Disease Research in Zambia (CIDRZ) found low phosphorus levels to be a possible cause of mortality in the first 12 weeks following cART initiation. If efficacious, such a nutritional intervention could be scaled up across Africa at relatively low cost since it requires neither expensive drugs nor highly trained staff to administer.