Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial
ABSTRACT BACKGROUND: Multiple micronutrients (vitamin B complex and vitamins C and E) were effective at reducing infectious disease morbidity, HIV disease progression, and poor pregnancy outcomes in HIV-infected women. OBJECTIVE: The objective was to evaluate whether direct supplementation of these micronutrients to HIV-exposed infants reduces mortality and morbidity. DESIGN: Infants born to HIV-infected women from Dar es Salaam, Tanzania, were randomly assigned to receive daily oral supplementation of multiple multivitamins (vitamin B complex and vitamins C and E) or placebo from age 6 wk for 24 mo. All-cause mortality, hospitalizations, and unscheduled clinic visits were recorded. Morbidities were recorded during monthly follow-up visits. All mothers received multiple micronutrients throughout the study. RESULTS: A total of 1193 infants were randomly assigned to receive micronutrients and 1194 to receive placebo. There were 138 child deaths in the multivitamin group and 124 deaths in the placebo group (HR: 1.13; 95% CI: 0.88, 1.44; P = 0.33). Hospitalizations (RR: 0.83; 95% CI: 0.62, 1.13; P = 0.23), unscheduled clinic visits (RR: 0.97; 95% CI: 0.85, 1.10; P = 0.59), and maternal reports of diarrhea (RR: 0.97; 0.87, 1.10; P = 0.64) were not significantly different between the 2 groups. Fever (P = 0.02) and vomiting (P = 0.007) were significantly lower in the multivitamin group. Among 429 children whose mothers received antiretroviral (ARV) therapy, multivitamin use had no effect on mortality but was associated with a significant reduction in hospitalizations (P = 0.035), episodes of fever (P = 0.005), and episodes of fever and cough (P = 0.019). CONCLUSIONS: In the setting of maternal micronutrient supplementation, supplementation of HIV-exposed infants with vitamin B and vitamins C and E does not reduce mortality. Studies of nutrition supplementation in ARV-exposed infants may be warranted. This trial was registered at clinicaltrials.gov as NCT00197730.
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ABSTRACT: Growth faltering and micronutrient deficiencies commonly coexist in HIV-exposed children in sub-Saharan Africa, and correcting deficiencies, such as those of vitamins B-complex, C, and E, may improve HIV-related endpoints and child growth. We therefore examined the effect of daily oral supplementation of vitamins B-complex, C, and E on growth among 2341 children born to HIV-infected mothers in Tanzania. HIV-infected women pregnant at ≤32 wk of gestation were enrolled in the study. Children were randomized at age 6 wk to receive multivitamins or placebo until age 104 wk. All women received the same types of vitamins pre- and postnatally. At 6 wk, 256 children (11.1%) were HIV infected and the mean (SD) Z-scores for length for age (LAZ), weight for length (WLZ), and weight for age (WAZ) were -0.39 ± 1.20, -0.21 ± 1.23, and -0.52 ± 1.11, respectively. There was no overall treatment effect on LAZ, WLZ, or WAZ profiles during the follow-up (P ≥ 0.15). There was no treatment effect from 6 to 104 wk on LAZ [(95% CI: -0.14, 0.13); P = 0.94], WLZ [(95% CI: -0.17, 0.13); P = 0.78], or WAZ [(95% CI: -0.15, 0.16); P = 0.97] or on the incidence of growth failure, defined as respective Z-scores < -2 (P ≥ 0.29). Among the subgroup of HIV-uninfected children, there was no treatment effect from 6 to 104 wk on LAZ, WLZ, and WAZ (P ≥ 0.71) or on the incidence of growth failure (P ≥ 0.16). Multivitamin supplements had no effect on growth among children born to HIV-infected women who were themselves receiving multivitamins.Journal of Nutrition 03/2013; 143(5). DOI:10.3945/jn.112.170498 · 4.23 Impact Factor
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ABSTRACT: Vitamin D is essential for bone development and may also play an integral role in control of intracellular pathogens. Serum 25-hydroxyvitamin D levels were assessed at 6 months of age for 191 HIV-exposed uninfected infants enrolled in a trial of multivitamins (not including vitamin D) in Tanzania. A total of 66 infants (34.6%) were classified as vitamin D deficient (<20 ng/ml), 93 (48.7%) as vitamin D insufficient (20-30 ng/ml) and 32 (16.8%) as vitamin D sufficient (≥30 ng/ml). Independent risk factors for vitamin D deficiency were sampling during the rainy season and infant wasting. Infant breastfeeding, maternal CD4 T-cell count, maternal wasting status and maternal receipt of antiretroviral therapy were not associated with vitamin D deficiency. Low levels of vitamin D were highly prevalent among HIV-exposed uninfected infants in Tanzania, and longitudinal studies and clinical trials of supplementation are needed to assess the impact on child health.Journal of Tropical Pediatrics 04/2013; 59(5). DOI:10.1093/tropej/fmt028 · 0.86 Impact Factor
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ABSTRACT: Immunization and nutritional interventions are mainstays of child health programs in sub-Saharan Africa, yet few published data on their interaction exist. HIV-exposed infants (uninfected) enrolled in a randomized placebo-controlled trial of multivitamins (vitamin B-complex, C and E) conducted in Tanzania were sampled for assessment of measles IgG quantity and avidity at 15-18 months. Infants were vaccinated between 8.5-12 months and all mothers received high dose multivitamins as standard of care. Of 201 HIV-exposed infants enrolled, 138 (68.7%) were measles seropositive. There was no effect of infant multivitamin supplementation on measles seroconversion proportions, IgG concentrations, and IgG avidity (p>0.05). The measles seroconversion proportion was greater for HIV-exposed infants vaccinated at 10-11 as compared to 8.5-10 months (p=0.032), and for infants whose mothers had a CD4 T-cell count <200 cells/μL as compared to >350 cells/μL (p=0.039). Stunted infants had significantly decreased IgG quantity as compared to non-stunted infants (p=0.012). As for measles avidity, HIV-exposed infants vaccinated at 10-11 months had increased antibody avidity (p=0.031). Maternal CD4 T-cell counts <200 cells/μL were associated with decreased avidity as compared to >350 cells/μL (p=0.047), as were lower infant height-for-age z-scores (p=0.016). Supplementation with multivitamins containing B-complex, C, and E does not appear to improve measles vaccine response for HIV-exposed infants. Studies are needed to better characterize the impact of maternal HIV disease severity on immune system development of HIV-exposed infants and the effect of malnutrition interventions on vaccine responses.Clinical and vaccine Immunology: CVI 05/2013; 20(8). DOI:10.1128/CVI.00183-13 · 2.37 Impact Factor