• Davaasambuu Ganmaa, Buyanjargal Uyanga, Xin Zhou, Garmaa Gantsetseg, Baigali Delgerekh, Davaasambuu Enkhmaa, Dorjnamjil Khulan, Saranjav Ariunzaya, Erdenebaatar Sumiya, Batbileg Bolortuya, Jutmaan Yanjmaa, Tserenkhuu Enkhtsetseg, Ankhbat Munkhzaya, Murneren Tunsag, Polyna Khudyakov, James A Seddon, Ben J Marais, Ochirbat Batbayar, Ganbaatar Erdenetuya, Bazarsaikhan Amarsaikhan, Donna Spiegelman, Jadambaa Tsolmon, and Adrian R Martineau.
• From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).
• N. Engl. J. Med. 2020 Jul 23; 383 (4): 359368359-368.

BackgroundVitamin 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.MethodsWe 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.ResultsA 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.ConclusionsVitamin 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.).Copyright © 2020 Massachusetts Medical Society.

28 keywords...

hide…