Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial
Wejse C, Gomes VF, Rabna P, Gustafson P, Aaby P, Lisse IM, Andersen PL, Glerup H, Sodemann M
American journal of respiratory and critical care medicine · 274 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
- Universidad u hospital
- Aarhus Universitetshospital
- Universidad u hospital
- Aarhus University Hospital
Según 2 financiadores declarados.
Publicación
- Publicado
- 2009-01-29 · Am J Respir Crit Care Med · vol. 179 · número 9 · págs. 843–850
- Editorial
- American Thoracic Society
- Citado
- 395 citas · más que el 100% de estudios similares · 29.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 37 trabajos
- Acceso
- De pago
- Áreas de investigación
- Tuberculosis Research and Epidemiology · Vitamin D Research Studies · Infectious Diseases and Tuberculosis
- Palabras clave
- vitamin D supplementation, vitamin D3, tuberculosis, pulmonary tuberculosis, tuberculosis treatment, mortality, clinical severity score, sputum smear conversion, HIV coinfection, host immune response, hypercalcemia, dose adequacy
- MeSH
- humans, tuberculosis, pulmonary, hiv infections, vitamin d deficiency, weight gain, cholecalciferol, vitamins, vitamin d, antitubercular agents, cd4 lymphocyte count, drug therapy, combination, double-blind method, adult, guinea-bissau, female, male
9 autores
- Christian Morberg Wejse🇬🇼🇩🇰Bandim Health Project; Aarhus University Hospital
- Victor Francisco Gomes🇬🇼Bandim Health Project
- Paulo Rabna🇬🇼Bandim Health Project
- Per Gustafson🇬🇼🇸🇪Bandim Health Project; Lund University
- Peter Aaby🇬🇼Bandim Health Project
- Ida Maria Lisse🇩🇰Herlev Hospital; Copenhagen University Hospital
- Paul Lehm Andersen🇩🇰Aarhus University Hospital
- Henning Glerup🇩🇰Aarhus University Hospital
- Morten Sodemann🇬🇼🇩🇰Bandim Health Project; Odense University Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Rationale
Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis.
Objectives
To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality.
Methods
We conducted a randomized, double-blind, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment.
Measurements and main results
The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at 1 year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2.
Conclusions
Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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