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Tuberculosis not treated by lots of vitamin D for 16 weeks – RCT Sept 2015

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

Am J Clin Nutr. 2015 Sep 23. pii: ajcn113886. [Epub ahead of print]
Tukvadze N1, Sanikidze E1, Kipiani M1, Hebbar G2, Easley KA3, Shenvi N3, Kempker RR4, Frediani JK5, Mirtskhulava V6, Alvarez JA5, Lomtadze N1, Vashakidze L1, Hao L2, Del Rio C7, Tangpricha V8, Blumberg HM9, Ziegler TR10.

VitaminDWiki Summary

Initially 74% of TB subjects had <20 ng of vitamin D
Loading dose of 50,000 IU 3 times per week for 8 weeks (1,200,000 IU)
Peak vitamin D level at end of loading dose ~ 80 ng
Followed by 50,000 IU every 2 weeks
Final Vitamin D level ~ 50 ng
VitaminDWiki question: Wonder why this did not help?
Genes, Vitamin D Binding Protein, Vitamin D Receptor
Did the vitamin D treatment group not get the TB drug that the placebo group got?
See also VitaminDWiki

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 vs. placebo groups [29 vs. 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% vs. 82.1% for vitamin D3 vs. placebo; 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.

© 2015 American Society for Nutrition.
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