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Randomized Controlled Trial
High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial.
- Nestan Tukvadze, Ekaterina Sanikidze, Maia Kipiani, Gautam Hebbar, Kirk A Easley, Neeta Shenvi, Russell R Kempker, Jennifer K Frediani, Veriko Mirtskhulava, Jessica A Alvarez, Nino Lomtadze, Lamara Vashakidze, Li Hao, Carlos Del Rio, Vin Tangpricha, Henry M Blumberg, and Thomas R Ziegler.
- National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia;
- Am. J. Clin. Nutr. 2015 Nov 1; 102 (5): 1059-69.
BackgroundTuberculosis, 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.ObjectiveWe determined whether adjunctive high-dose vitamin D3 supplementation improves outcomes in individuals with pulmonary tuberculosis disease.DesignThe 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.ResultsBaseline 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).ConclusionA 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.© 2015 American Society for Nutrition.
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