Open Access Research

A randomized trial of multivitamin supplementation in children with tuberculosis in Tanzania

Saurabh Mehta1*, Ferdinand M Mugusi2, Ronald J Bosch3, Said Aboud4, Anirban Chatterjee5, Julia L Finkelstein1, Maulidi Fataki6, Rodrick Kisenge6 and Wafaie W Fawzi7

Author Affiliations

1 Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA

2 Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

3 Department of Biostatistics, Harvard School of Public Health, Boston, MA 02115, USA

4 Departments of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

5 UNICEF, New York, NY, USA

6 Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

7 Departments of Nutrition, Epidemiology, and Global Health and Population, Harvard School of Public Health, Boston, MA 02115, USA

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Nutrition Journal 2011, 10:120  doi:10.1186/1475-2891-10-120

Published: 31 October 2011

Abstract

Background

Children 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.

Methods

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.

Results

There 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).

Conclusions

Multivitamin 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 Identifier

NCT00145184