High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial. Issue 5 (23rd September 2015)

• Record Type: Journal Article
• 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
• Is Part Of: American journal of clinical nutrition. Volume 102:Issue 5(2015)
• Page Start: 1059
• Page End: 1069
• Publication Date: 2015-09-23
• Subjects: multidrug-resistant tuberculosis -- Mycobacterium tuberculosis -- randomized controlled trial -- tuberculosis -- vitamin D; Diet therapy -- Periodicals; Nutrition -- Periodicals; Dietetics -- Periodicals; 613.205
• DOI: 10.3945/ajcn.115.113886
• Languages: English
• ISSNs: 0002-9165

Abstract

ABSTRACT: 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.