Multiple micronutrient supplementation does not reduce diarrhoea morbidity in Ugandan HIV-infected children: a randomised controlled trial

Abstract

Objectives: To determine the effect of multiple micronutrient supplementation on the incidence and prevalence of diarrhoea in Ugandan HIV-infected children aged 1–5 years.Methods: We enrolled 847 HIV-infected Ugandan children in a randomised trial of a supplement containing 14 micronutrients (MMS) given at twice the recommended dietary allowance (RDA) versus a six-multivitamin (MV) supplement given in one RDA as the ‘standard of care’. The participants were stratified into a highly active antiretroviral therapy (HAART) group of 85/847 (10%) and a non-HAART group of 762/847 (90%) participants. The supplements were given daily for 6 months. Episodes of diarrhoea assessed at routine visits, sick visits and those reported within 2 weeks before the routine visit were counted against weeks of observation for each participant. Diarrhoea incidence per child was calculated as the number of episodes per child year. Rate ratios were used to compare person–time rates in the two groups.Results: The incidence of diarrhoea was 3·8 (95% CI 3·4–4·3) in the MMS and 3·5 (95% CI 3·1–4·0) in the MV group per child year. The rate ratio was 1·1 (0·9–1·3), similar in both strata, except that HAART-treated children had a lower incidence rate of diarrhoea. The prevalence of diarrhoea at 6 months was also similar in the two groups.Conclusion: The 14-multiple-micronutrient supplement given in two RDA doses compared with a six-multivitamin ‘standard of care’ supplement given in one RDA dose did not reduce the incidence or prevalence of diarrhoea in HIV-infected children aged 1–5 years.