| Summary: | <p>Abstract</p> <p>Background</p> <p>Vitamin D enhances host protective immune responses to <it>Mycobacterium tuberculosis</it> by suppressing Interferon-gamma (IFN-g) and reducing disease associated inflammation in the host. The objectives of this study were to determine whether vitamin D supplementation to patients with tuberculosis (TB) could influence recovery.</p> <p>Methods</p> <p>Two hundred and fifty nine patients with pulmonary TB were randomized to receive either 600,000 IU of Intramuscular vitamin D<sub>3</sub> or placebo for 2 doses. Assessments were performed at 4, 8 and 12 weeks. Early secreted and T cell activated 6 kDa (ESAT6) and <it>Mycobacterium tuberculosis</it> sonicate (MTBs) antigen induced whole blood stimulated IFN-g responses were measured at 0 and 12 weeks. Statistical comparisons between outcome variables at 0 and 12 weeks were performed using Student’s <it>t</it>-test and Chi<sup>2</sup> tests.</p> <p>Results</p> <p>After 12 weeks, the vitamin D supplemented arm demonstrated significantly <it>greater</it> mean weight gain (kg) + 3.75, (3.16 – 4.34) versus + 2.61 (95% CI 1.99 – 3.23) <it>p</it> 0.009 and <it>lesser</it> residual disease by chest radiograph; number of zones involved 1.35 v/s 1.82 <it>p</it> 0.004 (95% CI 0.15, 0.79) and 50% or greater reduction in cavity size 106 (89.8%) v/s 111 (94.8%), <it>p</it> 0.035. Vitamin D supplementation led to significant increase in MTBs-induced IFN-g secretion in patients with baseline ‘Deficient’ 25-hydroxyvitamin D serum levels (<it>p</it> 0.021).</p> <p>Conclusions</p> <p>Supplementation with high doses of vitamin D accelerated clinical, radiographic improvement in all TB patients and increased host immune activation in patients with baseline ‘Deficient’ serum vitamin D levels. These results suggest a therapeutic role for vitamin D in the treatment of TB.</p> <p>Trial registration</p> <p>ClinicalTrials.gov; No. <it>NCT01130311</it>; URL: <it>clinicaltrials.gov</it></p>
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