Adjunctive vitamin D for treatment of active tuberculosis in India: a randomised, double-blind, placebo-controlled trial
Daley P, Jagannathan V, John KR, Sarojini J, Latha A, Vieth R, Suzana S, Jeyaseelan L, Christopher DJ, Smieja M, Mathai D
The Lancet. Infectious diseases · 105 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Dalhousie University
Según 1 financiador declarado.
Publicación
- Publicado
- 2015-04-11 · Lancet Infect Dis · vol. 15 · número 5 · págs. 528–534
- Editorial
- Elsevier BV
- Citado
- 138 citas · más que el 99% de estudios similares · 15.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 29 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, active pulmonary tuberculosis, sputum conversion, adjunctive therapy, immunomodulation, tuberculosis treatment, hypercalcemia
- MeSH
- sputum, humans, mycobacterium tuberculosis, tuberculosis, pulmonary, vitamin d, immunologic factors, antibodies, bacterial, antitubercular agents, treatment outcome, combined modality therapy, double-blind method, dietary supplements, adolescent, adult, aged, middle aged, female, male
11 autores
- Peter Daley🇨🇦 · autor de correspondenciaMemorial University of Newfoundland
- Vijayakumar Jagannathan🇮🇳Christian Medical College, Vellore
- K. R. John
- J Sarojini🇮🇳Christian Medical College, Vellore
- Asha Latha🇮🇳Christian Medical College, Vellore
- Reinhold Vieth🇨🇦University of Toronto
- Shirly Suzana🇮🇳Christian Medical College, Vellore
- Lakshmanan Jeyaseelan🇮🇳Christian Medical College, Vellore
- Devasahayam Jesudas Christopher🇮🇳Christian Medical College, Vellore
- Marek Smieja🇨🇦McMaster University
- Dilip C. Mathai🇮🇳Apollo Institute of Medical Sciences & Research
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Vitamin D has immunomodulatory effects that might aid clearance of mycobacterial infection. We aimed to assess whether vitamin D supplementation would reduce time to sputum culture conversion in patients with active tuberculosis.
Methods
We did this randomised, double-blind, placebo-controlled, superiority trial at 13 sites in India. Treatment-naive patients who were sputum-smear positive, HIV negative, and had pulmonary tuberculosis were randomly assigned (1:1), with centrally labelled, serially numbered bottles, to receive standard active tuberculosis treatment with either supplemental high-dose oral vitamin D3 (four doses of 2·5 mg at weeks 0, 2, 4, and 6) or placebo. Neither the patients nor the clinical and laboratory investigators and personnel were aware of treatment assignment. The primary efficacy outcome was time to sputum culture conversion. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00366470.
Findings
Between Jan 20, 2010, and Aug 23, 2011, we randomly assigned 247 participants to the vitamin D group (n=121) or the placebo group (n=126), of whom 211 participants (n=101 and n=110, respectively) were included in the primary efficacy analysis. Median time to culture conversion in the vitamin D group was 43·0 days (95% CI 33·3-52·8) versus 42·0 days (33·9-50·1) in the placebo group (log-rank p=0·95). Three (2%) patients died in the vitamin D group and one (1%) patient died in the placebo group; no death was considered attributable to the study intervention. No patients had hypercalcaemia.
Interpretation
Our findings show that vitamin D supplementation did not reduce time to sputum culture conversion. Further studies should investigate the role of vitamin D in prevention or reactivation of tuberculosis infection.
Funding
Dalhousie University and Infectious Diseases Training and Research Centre.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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