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Multiple micronutrient supplementation improves vitamin B?? and folate concentrations of HIV infected children in Uganda: a randomized controlled trial.

ABSTRACT: The effect of multiple micronutrient supplementation on vitamin B?? and folate has hither to not been reported in African HIV infected children. This paper describes vitamin B?? and folate status of Ugandan HIV infected children aged 1-5 years and reports the effect of multiple micronutrient supplementation on serum vitamin B12 and folate concentrations.Of 847 children who participated in a multiple micronutrient supplementation trial, 214 were assessed for vitamin B?? and folate concentrations pre and post supplementation. One hundred and four children were randomised to two times the recommended dietary allowance (RDA) of a 14 multiple micronutrient supplement (MMS) and 114 to a 'standard of care' supplement of 6 multivitamins (MV). Serum vitamin B12 was measured by an electrochemiluminescence immunoassay and folate by a competitive protein-binding assay using Modular E (Roche) automatic analyzer. Vitamin B?? concentrations were considered low if less than 221 picomoles per litre (pmol/L) and folate if < 13.4 nanomoles per litre (nmol/L). The Wilcoxon Signed Ranks test was used to measure the difference between pre and post supplementation concentrations.Vitamin B?? was low in 60/214 (28%) and folate in 62/214 (29.0%) children. In the MMS group, the median concentration (IQR) of vitamin B?? at 6 months was 401.5 (264.3 - 518.8) pmol/L compared to the baseline of 285.5 (216.5 - 371.8) pmol/L, p < 0.001. The median (IQR) folate concentrations increased from 17.3 (13.5-26.6) nmol/L to 27.7 (21.1-33.4) nmol/L, p < 0.001. In the 'standard of care' MV supplemented group, the median concentration (IQR) of vitamin B?? at 6 months was 288.5 (198.8-391.0) pmol/L compared to the baseline of 280.0 (211.5-386.3) pmol/L while the median (IQR) folate concentrations at 6 months were 16.5 (11.7-22.1) nmol/L compared to 15.7 (11.9-22.1) nmol/L at baseline. There was a significant difference in the MMS group in both vitamin B?? and folate concentrations but no difference in the MV group.Almost a third of the HIV infected Ugandan children aged 1-5 years had low serum concentrations of vitamin B?? and folate. Multiple micronutrient supplementation compared to the 'standard of care' supplement of 6 multivitamins improved the vitamin B12 and folate status of HIV infected children in Uganda.http://ClinicalTrials.govNCT00122941).

SUBMITTER: Ndeezi G

PROVIDER: S-EPMC3118332 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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Multiple micronutrient supplementation improves vitamin B₁₂ and folate concentrations of HIV infected children in Uganda: a randomized controlled trial.

Ndeezi Grace G Tumwine James K JK Ndugwa Christopher M CM Bolann Bjørn J BJ Tylleskär Thorkild T

Nutrition journal 20110521

<h4>Background</h4>The effect of multiple micronutrient supplementation on vitamin B₁₂ and folate has hither to not been reported in African HIV infected children. This paper describes vitamin B₁₂ and folate status of Ugandan HIV infected children aged 1-5 years and reports the effect of multiple micronutrient supplementation on serum vitamin B12 and folate concentrations.<h4>Methods</h4>Of 847 children who participated in a multiple micronutrient supplementation trial, 214 were assessed for vit ...[more]

PMID: 21600005

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Project description: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.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.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.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.ClinicalTrials.gov Identifier: NCT00122941.

Project description:BACKGROUND:Heightened immune activation and exhaustion drive HIV disease progression and comorbidities. Vitamin D has pleiotropic immunomodulatory effects, but little is known about the effects of supplementation in HIV. Our study investigates changes in immune activation and exhaustion markers after 12 months of supplementation in virologically suppressed HIV-infected youth with vitamin D insufficiency. METHODS:This is a randomized, active-control, double-blind trial investigating with three different vitamin D3 doses (18,000 [standard/active-control dose], 60,000 [moderate dose] and 120,000 IU/month [high dose]) in 8-25-year-old HIV-infected youth on combination antiretroviral therapy with baseline serum 25-hydroxyvitamin D (25(OH)D) concentrations ?30 ng/ml. Only subjects (n=51) who maintained an undetectable HIV-1 RNA over the 12-month study period were included in this analysis. RESULTS:Baseline serum 25(OH)D concentrations and immune activation/exhaustion markers were not different between groups. By 12 months, 25(OH)D increased significantly within each dosing group with the greatest increase and most sustained concentrations ?30 ng/ml in the high-dose group. Overall, all measured markers decreased with CD4 activation (CD4+CD38+HLA-DR+), CD8 activation (CD8+CD38+HLA-DR+), CD4 exhaustion (CD4+CD38+HLA-DR+PD1+) and inflammatory monocytes (CD14+CD16+) reaching statistical significance. When analysed separately, there were no significant decreases in the moderate- or standard-dose groups, but CD4 and CD8 activation and inflammatory monocytes decreased significantly in the high-dose group. CONCLUSIONS:Vitamin D supplementation decreased markers of T-cell activation/exhaustion and monocyte activation in HIV-infected youth, with subjects given the highest dose (120,000 IU/month) showing the greatest decreases. These data suggest that high-dose vitamin D supplementation may attenuate immune activation and exhaustion, and serve as adjuvant therapy to antiretroviral therapy in HIV. ClinicalTrials.gov identifier: NCT01523496.

Dataset Information

Multiple micronutrient supplementation improves vitamin B?? and folate concentrations of HIV infected children in Uganda: a randomized controlled trial.

Publications

Multiple micronutrient supplementation improves vitamin B₁₂ and folate concentrations of HIV infected children in Uganda: a randomized controlled trial.

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