Vitamin D as Supplementary Treatment for Tuberculosis: A Double-blind Randomized Placebo-controlled Trial

RATIONALE: Vitamin D has been shown to be involved in host immune response towards M. tuberculosis. OBJECTIVE: To test whether vitamin D supplementation of TB patients improved clinical outcome and reduced mortality. METHODS: We conducted a randomized double-blind placebo-controlled trial in TB clinics at a Demographic Surveillance Site in Guinea Bissau. We included 365 adult TB patients starting anti-tuberculosis treatment, 281 completed 12 month follow-up. The intervention was 100,000 IU cholecalciferol or placebo at inclusion and again at 5 and 8 months after start of treatment. Measurements and results: The primary outcome was reduction in a clinical severity score (TBscore) for all pulmonary TB patients. The secondary outcome was 12-months mortality. No serious adverse effects were reported, mild hypercalcaemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among vitamin D and placebo treated patients. Overall mortality was 15% (54/365) at one year follow up and similar in both arms (30/187 for vitamin D treated and 24/178 for placebo, RR=1.19 [0.72-1.95]). HIV infection was seen in 36% (131/359), 21% (76/359) HIV-1, 10% (36/359) HIV-2 and 5% (19/357) HIV-1+2. CONCLUSIONS: Vitamin D does not improve clinical outcome among TB patients and the trial showed no overall effect on mortality in TB patients but the dose used may be insufficient. Trial registration: Current Controlled Trials Register number ISRCTN35212132 at www.controlled-trials.com/isrctn.