High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial12

• Published in: The American journal of clinical nutrition Vol. 102; no. 5; pp. 1059 - 1069
• Main Authors: Tukvadze, Nestan, Sanikidze, Ekaterina, Kipiani, Maia, Hebbar, Gautam, Easley, Kirk A, Shenvi, Neeta, Kempker, Russell R, Frediani, Jennifer K, Mirtskhulava, Veriko, Alvarez, Jessica A, Lomtadze, Nino, Vashakidze, Lamara, Hao, Li, Del Rio, Carlos, Tangpricha, Vin, Blumberg, Henry M, Ziegler, Thomas R
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01-11-2015; American Society for Nutrition
• Subjects: multidrug-resistant tuberculosis; Mycobacterium tuberculosis; randomized controlled trial; tuberculosis; vitamin D; Vitamins, Minerals, and Phytochemicals; RCT; VDR; vitamin D; tuberculosis; MDR-TB; multidrug-resistant tuberculosis; randomized controlled trial; Mycobacterium tuberculosis; CRF; 25(OH)D; Mtb; VitDQAP; AFB; NCTLD
• ISSN: 0002-9165; 1938-3207
• DOI: 10.3945/ajcn.115.113886

Background: Tuberculosis, including multidrug-resistant tuberculosis (MDR-TB), is a major global health problem. Individuals with tuberculosis disease commonly exhibit vitamin D deficiency, which may adversely affect immunity and the response to therapy.
Objective: We determined whether adjunctive high-dose vitamin D3 supplementation improves outcomes in individuals with pulmonary tuberculosis disease.
Design: The study was a double-blind, randomized, placebo-controlled, intent-to-treat trial in 199 individuals with pulmonary tuberculosis disease in Tbilisi, Georgia. Subjects were randomly assigned to receive oral vitamin D3 [50,000 IUs (1.25 mg) thrice weekly for 8 wk and 50,000 IU every other week for 8 wk] or a placebo concomitant with standard first-line antituberculosis drugs. The primary outcome was the time for the conversion of a Mycobacterium tuberculosis (Mtb) sputum culture to negative.
Results: Baseline characteristics between groups were similar. Most subjects (74%) were vitamin D deficient (plasma 25-hydroxyvitamin D [25(OH)D] concentration <50 nmol/L). With vitamin D3, plasma 25(OH)D concentrations peaked at ∼250 nmol/L by 8 wk and decreased to ∼125 nmol/L at week 16. Adverse events and plasma calcium concentrations were similar between groups. In 192 subjects with culture-confirmed tuberculosis, an adjusted efficacy analysis showed similar median culture-conversion times between vitamin D3 and placebo groups [29 and 27 d, respectively; HR: 0.86; 95% CI: 0.63, 1.18; P = 0.33). Eight-week culture-conversion rates were also similar (84.0% and 82.1% for vitamin D3 and placebo, respectively; P = 0.99).
Conclusion: A high-dose vitamin D3 regimen safely corrected vitamin D deficiency but did not improve the rate of sputum Mtb clearance over 16 wk in this pulmonary tuberculosis cohort. This trial was registered at clinicaltrials.gov at NCT00918086.