Abstract
BackgroundMicronutrient deficiencies compromise the survival of HIV-infected children in low-income countries. We assessed the effect of multiple micronutrient supplementation on the mortality of HIV-infected children in Uganda.MethodsIn a randomized, controlled trial, 847 children aged one to five years and attending HIV clinics in Uganda were stratified by antiretroviral therapy (ART, n = 85 versus no ART, n = 762). The children were randomized to six months of either: twice the recommended dietary allowance of 14 micronutrients as the intervention arm (vitamins A, B1, B2, niacin, B6, B12, C, D and E, folate, zinc, copper, iodine and selenium); or the standard recommended dietary allowance of six multivitamins (vitamins A, D2, B1, B2, C and niacin) as a comparative "standard-of-care" arm. Mortality was analyzed at 12 months of follow up using Kaplan Meier curves and the log rank test.ResultsMortality at 12 months was 25 out of 426 (5.9%) children in the intervention arm and 28 out of 421 (6.7%) in the comparative arms: risk ratio 0.9 (95% CI 0.5 - 1.5). Two out of 85 (2.4%) children in the ART stratum died compared with 51 out of 762 (6.7%) in the non-ART stratum. Of those who died in the non-ART stratum, 25 of 383 (6.5%) were in the intervention arm and 26 of 379 (6.9%) in the comparative arm; risk ratio 1.0 (95% CI 0.6 - 1.6). There was no significant difference in survival at 12 months (p = 0.64, log rank test). In addition, there was no significant difference in mean weight-for-height at 12 months; 0.70 ± 1.43 (95% CI 0.52 - 0.88) for the intervention versus 0.59 ± 1.15 (95% CI 0.45 - 0.75) in the comparative arm. The mean CD4 cell count; 1024 ± 592 (95% CI 942 - 1107) versus 1060 ± 553 (95% CI 985 - 1136) was also similar between the two groups.ConclusionsTwice the recommended dietary allowance of 14 micronutrients compared with a standard recommended dietary allowance of six multivitamins for six months was well tolerated, but it did not significantly alter mortality, growth or CD4 counts. Future intervention studies should carefully consider: (1) the composition and dosing of the supplements; and (2) the power needed to detect a difference between arms.Trial RegistrationClinicalTrials.gov Identifier: NCT00122941
Highlights
Micronutrient deficiencies compromise the survival of HIV-infected children in low-income countries
Children enrolled in other studies, those residing more than 15 kilometres from the clinic and those whose parents or caretakers were anticipating moving from the study area were excluded
A total of 1632 children aged 12 to 59 months attending paediatric HIV clinics at the study sites were screened for eligibility (Figure 1)
Summary
Micronutrient deficiencies compromise the survival of HIV-infected children in low-income countries. We assessed the effect of multiple micronutrient supplementation on the mortality of HIV-infected children in Uganda. Mortality in HIV-infected children living in low-income countries is still high compared with high-income countries [1,2]. Micronutrients are important for maintaining optimal functioning of the individual's immune response. Selenium and vitamin E are involved in the maintenance of the oxidant defence system, while zinc and vitamin A play a significant role in maintaining cellular integrity [7]. Vitamin B12 is important in the formation of proteins and proper functioning of a large number of enzymes and the immune system [8]. Vitamin A and zinc deficiencies are associated with increased susceptibility to infections, increased severity of illness and mortality [10,11]
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