Vitamin D does not lower TB risk in children
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Findings from a years-long phase 3, double-blind, randomized, placebo-controlled trial of vitamin D supplementation in Mongolian school children showed that it did not lower the risk for tuberculosis.
In the study, Ganmaa Davaasambuu, MD, PhD, assistant professor of medicine at Harvard Medical School, and colleagues randomly assigned children who tested negative for Mycobacterium tuberculosis to receive either 14,000 IU of vitamin D or placebo every week for 3 years.
Based on previous research — including a meta-analysis that showed “vitamin D deficiency "predicts the risk of tuberculosis disease in a concentration-dependent manner” — Davaasambuu and colleagues “hypothesized that vitamin D supplementation would reduce the risk of tuberculosis infection and tuberculosis disease in populations in which both vitamin D deficiency and tuberculosis are prevalent.”
A total of 8,851 children participated in the trial, including 4,418 who received vitamin D supplementation and 4,433 who received placebo. Of the total number of children, 95.6% of them had a baseline serum 25-hydroxyvitamin D (25[OH]D) level of less than 20 ng/mL. By the end of the trial, 25(OH)D levels were elevated to the physiologic range of children assigned vitamin D, although the authors saw no difference in the proportion of children with evidence of TB infection.
Of those with a valid test result at the conclusion of the trial, 3.6% (n = 147) were positive in the vitamin D group, and 3.3% (n = 134) were positive in the placebo arm (adjusted RR, 1.10; 95% CI, 0.87-1.38), Davaasambuu and colleagues reported. The trial had no effect on the risk for any acute respiratory infections, they said.
According to the study, 21 children taking vitamin D and in 25 children taking placebo (aRR, 0.87; 95% CI, 0.49-1.55) were diagnosed with TB disease. Twenty-nine children taking vitamin D and 34 children taking placebo were hospitalized for an acute respiratory infection, (aRR, 0.86; 95% CI, 0.52-1.4).
Adverse events were balanced between the two groups, and no serious adverse events were due to vitamin D or the placebo, the authors wrote.
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