Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease.
What this study found
Weekly vitamin D3 markedly increased 25(OH)D but did not reduce Mycobacterium tuberculosis infection, tuberculosis disease, or acute respiratory infection versus placebo. For the primary endpoint, positive QFT at end occurred in 3.6% (147 of 4074) of the vitamin D group versus 3.3% (134 of 4043) of the placebo group, with an adjusted risk ratio of 1.10 (95% CI 0.87 to 1.38; P = 0.42). Tuberculosis disease was rare and similar between groups: 21 of 4401 (0.5%) versus 25 of 4418 (0.6%), adjusted RR 0.87 (95% CI 0.49 to 1.55); acute respiratory infection hospitalization was also similar at 29…
- Study & population
- Randomized placebo-controlled trial in vitamin D-deficient schoolchildren aged 6-13 years in 18 public schools in Ulaanbaatar, Mongolia.
- Intervention
- Vitamin D3 was given orally at 14,000 IU (0.35 mg) once weekly for 3 years.
- Key limitation
- The main outcomes were uncommon, especially tuberculosis disease, which limits power to detect modest effects.
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Open PDFOriginal abstract
BACKGROUND Vitamin D metabolites support innate immune responses to Mycobacterium tuberculosis. Data from phase 3, randomized, controlled trials of vitamin D supplementation to prevent tuberculosis infection are lacking. METHODS We randomly assigned children who had negative results for M. tuberculosis infection according to the QuantiFERON-TB Gold In-Tube assay (QFT) to receive a weekly oral dose of either 14,000 IU of vitamin D3 or placebo for 3 years. The primary outcome was a positive QFT result at the 3-year follow-up, expressed as a proportion of children. Secondary outcomes included the serum 25-hydroxyvitamin D (25[OH]D) level at the end of the trial and the incidence of tuberculosis disease, acute respiratory infection, and adverse events. RESULTS A total of 8851 children underwent randomization: 4418 were assigned to the vitamin D group, and 4433 to the placebo group; 95.6% of children had a baseline serum 25(OH)D level of less than 20 ng per milliliter. Among children with a valid QFT result at the end of the trial, the percentage with a positive result was 3.6% (147 of 4074 children) in the vitamin D group and 3.3% (134 of 4043) in the placebo group (adjusted risk ratio, 1.10; 95% confidence interval [CI], 0.87 to 1.38; P = 0.42). The mean 25(OH)D level at the end of the trial was 31.0 ng per milliliter in the vitamin D group and 10.7 ng per milliliter in the placebo group (mean between-group difference, 20.3 ng per milliliter; 95% CI, 19.9 to 20.6). Tuberculosis disease was diagnosed in 21 children in the vitamin D group and in 25 children in the placebo group (adjusted risk ratio, 0.87; 95% CI, 0.49 to 1.55). A total of 29 children in the vitamin D group and 34 in the placebo group were hospitalized for treatment of acute respiratory infection (adjusted risk ratio, 0.86; 95% CI, 0.52 to 1.40). The incidence of adverse events did not differ significantly between the two groups. CONCLUSIONS Vitamin D supplementation did not result in a lower risk of tuberculosis infection, tuberculosis disease, or acute respiratory infection than placebo among vitamin D-deficient schoolchildren in Mongolia. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02276755.).