S113High-dose vitamin D3 during intensive phase treatment of pulmonary tuberculosis in mongolia: a double-blind randomised controlled trial

Introduction and objectivesExisting trials of adjunctive vitamin D to enhance response to antimicrobial therapy for pulmonary tuberculosis are variously limited by relatively small sample sizes, inadequate dosing regimens and low baseline prevalence of vitamin D deficiency among participants. Our objective was to conduct a large randomised controlled trial of high-dose vitamin D in a setting where profound vitamin D deficiency was common in patients with pulmonary TB.MethodsWe conducted a double-blind randomised placebo-controlled trial of high-dose adjunctive vitamin D3 in adults with sputum smear-positive pulmonary tuberculosis in Ulaanbaatar, Mongolia. 390 participants were allocated to receive 3.5 mg vitamin D3 (n = 190) or placebo (n = 200) at baseline and at 2, 4 and 6 weeks after starting standard tuberculosis treatment. The primary endpoint of the trial was time from initiation of antimicrobial therapy to sputum culture conversion. Secondary endpoints were time to sputum smear conversion, resolution of infiltrates on chest radiograph and serum 25-hydroxyvitamin D (25[OH]D) concentrations. This trial was registered with ClinicalTrials.gov (NCT01657656).ResultsAt baseline, 81% of participants had profound vitamin D deficiency (serum 25[OH]D