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Efficacy and safety of high‐dose cholecalciferol in patients with pulmonary tuberculosis in Tbilisi, Georgia (250.7)
Author(s) -
Ziegler Thomas,
Tukvadze Nestan,
Kipiani Maia,
Sanikidze Eka,
Hebbar Gautam,
Ramakrishnan Usha,
Martorell Reynaldo,
Kempker Russell,
Tangpricha Vin,
Blumberg Henry
Publication year - 2014
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.28.1_supplement.250.7
Subject(s) - medicine , placebo , sputum , culture conversion , cholecalciferol , vitamin d and neurology , tuberculosis , sputum culture , gastroenterology , adverse effect , cohort , vitamin d deficiency , clinical trial , pathology , alternative medicine
Background: We tested whether high‐dose oral cholecalciferol (VD3) enhances efficacy of anti‐TB drugs in pulmonary TB infection. Methods: Double blind, randomized, controlled, intent‐to‐treat trial in adults with pulmonary TB in Tbilisi, Georgia. A total of 199 subjects were randomized to VD3 (1,400,000 IU; n=100) or placebo (n=99) over 16 weeks + standard anti‐TB drugs. Sputum TB cultures were obtained at weeks 0, 2, 4, 6, 8, 12 and 16. Cox analysis was used for the primary outcome (time to culture conversion). Results: Of 784 subjects screened, 100 received VD3 and 99 placebo. Most subjects (> 85%) were VD deficient at entry (serum 25OH VD level < 20 ng/mL). 23 subjects (12%) had multidrug‐resistant TB (MDR‐TB) (12 vitamin D, 11 placebo). Entry demographic factors were similar between groups. VD3 was safe, with similar blood calcium levels and adverse events between groups. With VD, serum 25OH VD levels peaked at ≍ 100 ng/mL at 8 weeks and decreased to ≍ 60 ng/mL by week 16. Culture conversion was similar between groups at 8 weeks and over time [HR=0.84 (0.62‐1.15)]. However, the MDR‐TB subset showed enhanced culture conversion with VD3 therapy vs. placebo at 8 weeks (40 vs. 88%) and over time (each p<0.04). Conclusions: High‐dose VD3 was safe and did not improve TB clearance in the overall cohort of TB patients. However, clinical efficacy in patients with MDR‐TB suggests that VD treatment trials focus on this subset of patients. Grant Funding Source : Supported by NIH/NIDDK K24 DK096574 and Emory Global Health Institute