Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease
Ganmaa D, Uyanga B, Zhou X, Gantsetseg G, Delgerekh B, Enkhmaa D, Khulan D, Ariunzaya S, Sumiya E, Bolortuya B, Yanjmaa J, Enkhtsetseg T, Munkhzaya A, Tunsag M, Khudyakov P, Seddon JA, Marais BJ, Batbayar O, Erdenetuya G, Amarsaikhan B, Spiegelman D, Tsolmon J, Martineau AR
The New England journal of medicine · 141 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Medical Research Council
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NHLBI NIH HHS
- Gobierno
- NCATS NIH HHS
- Subvenciones
- National Center for Advancing Translational Sciences (UL1TR001863Ð); National Heart, Lung, and Blood Institute (1R01HL122624-01); Medical Research Council (MR/R007942/1); National Heart, Lung, and Blood Institute (R01 HL122624)
Según 5 financiadores declarados.
Publicación
- Publicado
- 2020-07-22 · N Engl J Med · vol. 383 · número 4 · págs. 359–368
- Editorial
- Massachusetts Medical Society
- Citado
- 184 citas · más que el 95% de estudios similares · 3.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 31 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Tuberculosis Research and Epidemiology · Vitamin D Research Studies · Immune responses and vaccinations
- Palabras clave
- vitamin D supplementation, tuberculosis prevention, tuberculosis infection, tuberculosis, 25-hydroxyvitamin D, elementary school students, vitamin D deficiency, QuantiFERON-TB Gold, acute respiratory infections, Mongolia, adverse events
- MeSH
- humans, mycobacterium tuberculosis, respiratory tract infections, cholecalciferol, vitamins, vitamin d, tuberculin test, treatment failure, incidence, follow-up studies, double-blind method, dietary supplements, child, female, male, latent tuberculosis
23 autores
- Davaasambuu Ganmaa🇺🇸Brigham and Women's Hospital; Harvard University
- Uyanga Buyanjargal🇺🇸Brigham and Women's Hospital; Harvard University
- Xin Zhou🇺🇸Brigham and Women's Hospital; Harvard University; Yale University
- Gantsetseg Garmaa🇺🇸Brigham and Women's Hospital; Harvard University
- Baigali Delgerekh🇺🇸Brigham and Women's Hospital; Harvard University
- Davaasambuu Enkhmaa🇺🇸Brigham and Women's Hospital; Harvard University
- Dorjnamjil Khulan🇺🇸Brigham and Women's Hospital; Harvard University
- Saranjav Ariunzaya🇺🇸Brigham and Women's Hospital; Harvard University
- Sumiya Erdenebaatar🇺🇸Brigham and Women's Hospital; Harvard University
- Batbileg Bolortuya🇺🇸Brigham and Women's Hospital; Harvard University
- Jutmaan Yanjmaa🇺🇸Brigham and Women's Hospital; Harvard University
- Enkhtsetseg Tserenkhuu🇺🇸Brigham and Women's Hospital; Harvard University
- Munkhzaya Ankhbat🇺🇸Brigham and Women's Hospital; Harvard University
- Murneren Tunsag🇺🇸🇲🇳Brigham and Women's Hospital; Harvard University; National Center for Communicable Diseases
- Polyna Khudyakov🇺🇸Brigham and Women's Hospital; Harvard University
- James A. Seddon🇺🇸🇿🇦🇬🇧Brigham and Women's Hospital; Harvard University; Stellenbosch University; Imperial College London
- Ben J. Marais🇺🇸🇦🇺Brigham and Women's Hospital; The University of Sydney; Harvard University
- Batbayar Ochirbat🇺🇸Brigham and Women's Hospital; Harvard University
- Erdenetuya Ganbaatar🇺🇸🇲🇳Brigham and Women's Hospital; Harvard University; Mongolian National University of Medical Sciences
- Bazarsaikhan Amarsaikhan🇺🇸🇲🇳Brigham and Women's Hospital; Harvard University; Mongolian National University of Medical Sciences
- Donna L. Spiegelman🇺🇸Brigham and Women's Hospital; Harvard University; Yale University
- Jadambaa Tsolmon🇺🇸🇲🇳Brigham and Women's Hospital; Harvard University; Mongolian National University of Medical Sciences
- Adrian R. Martineau🇺🇸🇬🇧Brigham and Women's Hospital; Harvard University; Queen Mary University of London
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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