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Published on: October 6, 2022
Effect of multiple micronutrient supplementation on survival of HIV-infected children in Uganda: a randomized,
Grace Ndeezi1, Thorkild Tylleskär, Christopher M Ndugwa
1Department of Paediatrics and Child Health, Makerere University, Kampala, Uganda. gracendeezi@yahoo.com
Insights
Multiple micronutrient supplementation did not significantly reduce mortality in HIV-infected children in Uganda. The study found no significant differences in survival, growth, or CD4 counts between groups receiving high-dose or standard-dose multivitamins.
Area of Science:
- Pediatric Infectious Diseases
- Nutritional Science
- Public Health in Low-Income Countries
Background:
- Micronutrient deficiencies are a major threat to the survival of children with HIV in resource-limited settings.
- This study investigated the impact of multiple micronutrient supplementation on mortality rates in HIV-infected children in Uganda.
Purpose of the Study:
- To assess the effect of enhanced multiple micronutrient supplementation on the mortality of HIV-infected children.
- To evaluate the impact of supplementation on growth and CD4 cell counts.
Main Methods:
- A randomized controlled trial involving 847 children (aged 1-5 years) attending HIV clinics in Uganda.
- Children received either twice the recommended dietary allowance of 14 micronutrients or the standard recommended dietary allowance of 6 multivitamins for six months.
- Mortality was analyzed at 12 months using Kaplan-Meier curves and log-rank tests.
Main Results:
- Mortality at 12 months was 5.9% in the intervention arm and 6.7% in the standard care arm (Risk Ratio 0.9; 95% CI 0.5-1.5).
- No significant differences were observed in survival (p=0.64), mean weight-for-height, or mean CD4 cell counts between the groups.
- Children on antiretroviral therapy (ART) had lower mortality (2.4%) compared to those not on ART (6.7%).
Conclusions:
- Supplementation with twice the recommended dietary allowance of 14 micronutrients was well-tolerated but did not significantly impact mortality, growth, or CD4 counts in HIV-infected children.
- Future studies should consider supplement composition, dosage, and adequate statistical power to detect differences.
Background:
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.
Methods:
In 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.
Results:
Mortality 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.
Conclusions:
Twice 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 Registration:
ClinicalTrials.gov Identifier: NCT00122941.
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