title: A randomized trial of multivitamin supplementation in children with tuberculosis in Tanzania.
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.
authors: Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA. smehta@cornell.edu
authors: Saurabh
authors: S
authors: Mehta
authors: Ferdinand M
authors: FM
authors: Mugusi
authors: Ronald J
authors: RJ
authors: Bosch
authors: Said
authors: S
authors: Aboud
authors: Anirban
authors: A
authors: Chatterjee
authors: Julia L
authors: JL
authors: Finkelstein
authors: Maulidi
authors: M
authors: Fataki
authors: Rodrick
authors: R
authors: Kisenge
authors: Wafaie W
authors: WW
authors: Fawzi
mesh_terms: D000886:Anthropometry; D002675:Child, Preschool; D019587:Dietary Supplements; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications; D006801:Humans; D007223:Infant; D008297:Male; D013636:Tanzania / Q000453:epidemiology; D016896:Treatment Outcome; D014376:Tuberculosis / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology*; D014815:Vitamins / Q000008:administration & dosage*; D015430:Weight Gain / Q000187:drug effects
chemical_list: D014815:Vitamins