Abstract
BackgroundChildren with tuberculosis often have underlying nutritional deficiencies. Multivitamin supplementation has been proposed as a means to enhance the health of these children; however, the efficacy of such an intervention has not been examined adequately.Methods255 children, aged six weeks to five years, with tuberculosis were randomized to receive either a daily multivitamin supplement or a placebo in the first eight weeks of anti-tuberculous therapy in Tanzania. This was only 64% of the proposed sample size as the trial had to be terminated prematurely due to funding constraints. They were followed up for the duration of supplementation through clinic and home visits to assess anthropometric indices and laboratory parameters, including hemoglobin and albumin.ResultsThere was no significant effect of multivitamin supplementation on the primary endpoint of the trial: weight gain after eight weeks. However, significant differences in weight gain were observed among children aged six weeks to six months in subgroup analyses (n = 22; 1.08 kg, compared to 0.46 kg in the placebo group; 95% CI = 0.12, 1.10; p = 0.01). Supplementation resulted in significant improvement in hemoglobin levels at the end of follow-up in children of all age groups; the median increase in children receiving multivitamins was 1.0 g/dL, compared to 0.4 g/dL in children receiving placebo (p < 0.01). HIV-infected children between six months and three years of age had a significantly higher gain in height if they received multivitamins (n = 48; 2 cm, compared to 1 cm in the placebo group; 95% CI = 0.20, 1.70; p = 0.01; p for interaction by age group = 0.01).ConclusionsMultivitamin supplementation for a short duration of eight weeks improved the hematological profile of children with tuberculosis, though it didn't have any effect on weight gain, the primary outcome of the trial. Larger studies with a longer period of supplementation are needed to confirm these findings and assess the effect of multivitamins on clinical outcomes including treatment success and growth failure.Clinicaltrials.gov IdentifierNCT00145184
Highlights
Mycobacterium tuberculosis is one of the most successful pathogens known to man-both in terms of its longevity as well as in its ability to infect and cause disease in humans
Malnutrition and HIV infection increase this risk further [4,6,7]; for example, it is estimated that only one out of ten immunocompetent persons infected with TB develops active TB in his/her lifetime; whereas, one out of ten HIV-infected persons infected with TB will develop active TB every year [4]
There is limited data on the prevalence of micronutrient deficiencies among children with tuberculosis in resource-limited settings; in a trial of multivitamin supplementation in Tanzania, 22% and 15% of children born to HIV-infected women, who did not receive multivitamin supplementation, were deficient in vitamins E (< 11.6 μmol/L) and B12 levels (< 150 pmol/L), respectively [19]
Summary
255 children, aged six weeks to five years, with tuberculosis were randomized to receive either a daily multivitamin supplement or a placebo in the first eight weeks of anti-tuberculous therapy in Tanzania. This was only 64% of the proposed sample size as the trial had to be terminated prematurely due to funding constraints. They were followed up for the duration of supplementation through clinic and home visits to assess anthropometric indices and laboratory parameters, including hemoglobin and albumin
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