OBJECTIVE: As HIV has spread through sub-Saharan Africa, persistent diarrhoea has emerged as a major problem in hospitals and in the community in severely affected areas. We have previously demonstrated that antiprotozoal therapy with albendazole reduces diarrhoea in AIDS patients in urban Zambia. This trial was designed to test the hypothesis that the clinical response to albendazole might be improved by oral micronutrient supplementation. DESIGN: Randomized, placebo-controlled trial. SETTING: Home care service of Ndola Central Hospital, Zambia. PATIENTS: HIV-seropositive patients with persistent diarrhoea. INTERVENTION: Patients were randomized to albendazole plus vitamins A, C and E, selenium and zinc orally or albendazole plus placebo, for 2 weeks. MAIN OUTCOME MEASURES: Time with diarrhoea following completion of treatment; mortality; adverse events. RESULTS:Serum vitamin A and E concentrations before treatment were powerful predictors of early mortality, but supplementation did not reduce time with diarrhoea or mortality during the first month, even after taking into account initial vitamin A or E concentrations, CD4 cell count or clinical markers of illness severity. Serum concentrations of vitamins A and E did not increase significantly in supplemented patients compared with those given placebo, and there were no changes in CD4 cell count or haematological parameters. No adverse events were detected except those attributable to underlying disease. CONCLUSIONS: Although micronutrient deficiency is predictive of early death in Zambian patients with the diarrhoea-wasting syndrome, short-term oral supplementation does not overcome it nor influence morbidity or mortality.
RCT Entities:
OBJECTIVE: As HIV has spread through sub-Saharan Africa, persistent diarrhoea has emerged as a major problem in hospitals and in the community in severely affected areas. We have previously demonstrated that antiprotozoal therapy with albendazole reduces diarrhoea in AIDSpatients in urban Zambia. This trial was designed to test the hypothesis that the clinical response to albendazole might be improved by oral micronutrient supplementation. DESIGN: Randomized, placebo-controlled trial. SETTING: Home care service of Ndola Central Hospital, Zambia. PATIENTS: HIV-seropositivepatients with persistent diarrhoea. INTERVENTION: Patients were randomized to albendazole plus vitamins A, C and E, selenium and zinc orally or albendazole plus placebo, for 2 weeks. MAIN OUTCOME MEASURES: Time with diarrhoea following completion of treatment; mortality; adverse events. RESULTS: Serum vitamin A and E concentrations before treatment were powerful predictors of early mortality, but supplementation did not reduce time with diarrhoea or mortality during the first month, even after taking into account initial vitamin A or E concentrations, CD4 cell count or clinical markers of illness severity. Serum concentrations of vitamins A and E did not increase significantly in supplemented patients compared with those given placebo, and there were no changes in CD4 cell count or haematological parameters. No adverse events were detected except those attributable to underlying disease. CONCLUSIONS: Although micronutrient deficiency is predictive of early death in Zambian patients with the diarrhoea-wasting syndrome, short-term oral supplementation does not overcome it nor influence morbidity or mortality.
Authors: Kehinde S Okunade; Olusola F Olowoselu; Gbemisola E Osanyin; Sarah John-Olabode; Sulaimon A Akanmu; Rose I Anorlu Journal: Int J Gynaecol Obstet Date: 2018-04-23 Impact factor: 3.561