Dataset Information

Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease.

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.).

SUBMITTER: Ganmaa D

PROVIDER: S-EPMC7476371 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Publications

Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease.

Ganmaa Davaasambuu D Uyanga Buyanjargal B Zhou Xin X Gantsetseg Garmaa G Delgerekh Baigali B Enkhmaa Davaasambuu D Khulan Dorjnamjil D Ariunzaya Saranjav S Sumiya Erdenebaatar E Bolortuya Batbileg B Yanjmaa Jutmaan J Enkhtsetseg Tserenkhuu T Munkhzaya Ankhbat A Tunsag Murneren M Khudyakov Polyna P Seddon James A JA Marais Ben J BJ Batbayar Ochirbat O Erdenetuya Ganbaatar G Amarsaikhan Bazarsaikhan B Spiegelman Donna D Tsolmon Jadambaa J Martineau Adrian R AR

The New England journal of medicine 20200701 4

<h4>Background</h4>Vitamin D metabolites support innate immune responses to <i>Mycobacterium tuberculosis</i>. Data from phase 3, randomized, controlled trials of vitamin D supplementation to prevent tuberculosis infection are lacking.<h4>Methods</h4>We randomly assigned children who had negative results for <i>M. tuberculosis</i> infection according to the QuantiFERON-TB Gold In-Tube assay (QFT) to receive a weekly oral dose of either 14,000 IU of vitamin D<sub>3</sub> or placebo for 3 years. T ...[more]

PMID: 32706534

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Dataset Information

Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease.

Background

Methods

Results

Conclusions

Publications

Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease.

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