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Ensayo controlado aleatorizado2012Financiación no declarada

High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial

Lehouck A, Mathieu C, Carremans C, Baeke F, Verhaegen J, Van Eldere J, Decallonne B, Bouillon R, Decramer M, Janssens W

Annals of internal medicine · 259 citas

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Financiación no declarada

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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 no declarada

Publicación

Publicado
2012-01-17 · Ann Intern Med · vol. 156 · número 2 · págs. 105–114
Editorial
American College of Physicians
Citado
363 citas · más que el 100% de estudios similares · 30.3× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
38 trabajos
Acceso
De pago
Áreas de investigación
Vitamin D Research Studies · Chronic Obstructive Pulmonary Disease (COPD) Research · Asthma and respiratory diseases
Palabras clave
chronic obstructive pulmonary disease, vitamin D supplementation, high-dose vitamin D, COPD exacerbations, 25-hydroxyvitamin D, vitamin D deficiency, time to first exacerbation, hospitalization, FEV1, quality of life, mortality, airway inflammation, osteoporosis prevention
MeSH
sputum, humans, osteoporosis, pulmonary disease, chronic obstructive, recurrence, vitamin d, antimicrobial cationic peptides, forced expiratory volume, treatment outcome, cause of death, double-blind method, phagocytosis, quality of life, dietary supplements, aged, middle aged, female, male, cathelicidins

10 autores

  • An Lehouck🇧🇪Universitair Ziekenhuis Leuven
  • Chantal Mathieu🇧🇪Universitair Ziekenhuis Leuven
  • Claudia Carremans🇧🇪Universitair Ziekenhuis Leuven
  • Femke Baeke🇧🇪Universitair Ziekenhuis Leuven
  • Jan Verhaegen🇧🇪Universitair Ziekenhuis Leuven
  • Johan Van Eldere🇧🇪Universitair Ziekenhuis Leuven
  • Brigitte Decallonne🇧🇪Universitair Ziekenhuis Leuven
  • Roger Bouillon🇧🇪Universitair Ziekenhuis Leuven
  • Marc Decramer🇧🇪Universitair Ziekenhuis Leuven
  • Wim Janssens🇧🇪Universitair Ziekenhuis Leuven

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

Low serum 25-hydroxyvitamin D (25-[OH]D) levels have been associated with lower FEV(1), impaired immunologic control, and increased airway inflammation. Because many patients with chronic obstructive pulmonary disease (COPD) have vitamin D deficiency, effects of vitamin D supplementation may extend beyond preventing osteoporosis.

Objective

To explore whether supplementation with high doses of vitamin D could reduce the incidence of COPD exacerbations.

Design

Randomized, single-center, double-blind, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00666367)

Setting

University Hospitals Leuven, Leuven, Belgium.

Patients

182 patients with moderate to very severe COPD and a history of recent exacerbations.

Intervention

100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year.

Measurements

The primary outcome was time to first exacerbation. Secondary outcomes were exacerbation rate, time to first hospitalization, time to second exacerbation, FEV(1), quality of life, and death.

Results

Mean serum 25-(OH)D levels increased significantly in the vitamin D group compared with the placebo group (mean between-group difference, 30 ng/mL [95% CI, 27 to 33 ng/mL]; P < 0.001). The median time to first exacerbation did not significantly differ between the groups (hazard ratio, 1.1 [CI, 0.82 to 1.56]; P = 0.41), nor did exacerbation rates, FEV(1), hospitalization, quality of life, and death. However, a post hoc analysis in 30 participants with severe vitamin D deficiency (serum 25-[OH]D levels <10 ng/mL) at baseline showed a significant reduction in exacerbations in the vitamin D group (rate ratio, 0.57 [CI, 0.33 to 0.98]; P = 0.042).

Limitation

This was a single-center study with a small sample size.

Conclusion

High-dose vitamin D supplementation in a sample of patients with COPD did not reduce the incidence of exacerbations. In participants with severe vitamin D deficiency at baseline, supplementation may reduce exacerbations.

Primary funding source

Applied Biomedical Research Program, Agency for Innovation by Science and Technology (IWT-TBM).

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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