A randomized trial of efficacy and safety of adjunctive vitamin D in the treatment of active tuberculosis in India

Abstract

Background: Vitamin D supplementation may benefit patients with active tuberculosis (TB) Design: A randomized, double-blinded, placebo-controlled clinical trial comparing standard active TB treatment to active TB treatment plus supplemental high dose oral vitamin D3 was performed in India. Methods: Treatment naïve, smear positive, HIV negative, pulmonary TB patients were randomized into two equal groups. Results: 247 patients were randomized, 121 to vitamin D and 126 to placebo. Baseline characteristics in both groups were similar. 101 patients in the vitamin D arm and 110 patients in the placebo arm were analyzed. Median time to culture conversion in the vitamin D group was 43.0 days (95% C.I. = 33.3 to 52.8), as compared to was 42.0 days (33.9 to 50.1) in the placebo group (p=0.95 by log rank test). Hypercalcemia was not observed. Conclusions: Vitamin D supplementation was safe but did not influence time to culture conversion.