Financiado en parte por Amgen, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi, Gilead Sciences, Teva Pharmaceutical Industries, Novartis Pharmaceuticals Corporation, CSL Behring, Boston Scientific Corporation, Sunovion, Regeneron Pharmaceuticals, Cytokinetics, Genentech, Novartis Institutes for BioMedical Research
Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial
Castro M, King TS, Kunselman SJ, Cabana MD, Denlinger L, Holguin F, Kazani SD, Moore WC, Moy J, Sorkness CA, Avila P, Bacharier LB, Bleecker E, Boushey HA, Chmiel J, Fitzpatrick AM, Gentile D, Hundal M, Israel E, Kraft M, Krishnan JA, LaForce C, Lazarus SC, Lemanske R, Lugogo N, Martin RJ, Mauger DT, Naureckas E, Peters SP, Phipatanakul W, Que LG, Sheshadri A, Smith L, Solway J, Sullivan-Vedder L, Sumino K, Wechsler ME, Wenzel S, White SR, Sutherland ER, National Heart, Lung, and Blood Institute’s AsthmaNet
JAMA · 199 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- Financiado por la industria
- Organización sin fines de lucro
- Cystic Fibrosis Foundation
- Empresa
- Amgen
- Organización sin fines de lucro
- American Lung Association
- Empresa
- Pfizer
- Empresa
- AstraZeneca
- Empresa
- GlaxoSmithKline
- Empresa
- Sanofi
- Empresa
- Gilead Sciences
- Empresa
- Teva Pharmaceutical Industries
- Universidad u hospital
- Johns Hopkins University
- Empresa
- Novartis Pharmaceuticals Corporation
- Empresa
- CSL Behring
- Empresa
- Boston Scientific Corporation
- Empresa
- Sunovion
- Empresa
- Regeneron Pharmaceuticals
- Universidad u hospital
- National Jewish Health
- Empresa
- Cytokinetics
- Gobierno
- National Institutes of Health
- Empresa
- Genentech
- Empresa
- Novartis Institutes for BioMedical Research
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Institute of Allergy and Infectious Diseases
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NHLBI NIH HHS
- Gobierno
- NCATS NIH HHS
- Subvenciones
- National Heart, Lung, and Blood Institute (U10 HL098103); National Center for Advancing Translational Sciences (UL1-TR-000439); National Heart, Lung, and Blood Institute (HL098098); National Heart, Lung, and Blood Institute (HL098090); National Heart, Lung, and Blood Institute (U10 HL098075); National Heart, Lung, and Blood Institute (U10HL098090); National Center for Advancing Translational Sciences (UL 1 TR001082); National Center for Advancing Translational Sciences (UL1-TR-000448); National Heart, Lung, and Blood Institute (U10HL098112); National Heart, Lung, and Blood Institute (HL098115); National Heart, Lung, and Blood Institute (U10 HL098177); National Heart, Lung, and Blood Institute (HL098102); National Heart, Lung, and Blood Institute (HL098177); National Heart, Lung, and Blood Institute (U10 HL098107); National Heart, Lung, and Blood Institute (U10 HL098096); National Heart, Lung, and Blood Institute (HL098112); National Heart, Lung, and Blood Institute (U10HL098102); National Center for Advancing Translational Sciences (UL1 TR000150); National Heart, Lung, and Blood Institute (U10HL098098); National Center for Advancing Translational Sciences (UL1TR000050); National Heart, Lung, and Blood Institute (HL098107); National Heart, Lung, and Blood Institute (UL1TR000454); National Institutes of Health (UL1TR000427); National Institute of Allergy and Infectious Diseases (UL1TR000454); National Center for Advancing Translational Sciences (UL1 TR000454); National Heart, Lung, and Blood Institute (HL098103); National Institute of Allergy and Infectious Diseases (UL1 TR001082); National Heart, Lung, and Blood Institute (U10HL098115); National Heart, Lung, and Blood Institute (HL098075); National Heart, Lung, and Blood Institute (U10 HL074225); National Center for Advancing Translational Sciences (UL1 TR000005); National Institute of Allergy and Infectious Diseases (UL1TR000150); National Center for Advancing Translational Sciences (UL1 TR000430); National Institutes of Health (UL1‐TR000448); National Institutes of Health (UL1TR000439); National Institutes of Health (UL1-TR-001082); National Institutes of Health (UL1 TR000454); National Institutes of Health (HL098107); National Institutes of Health (HL098090); National Institutes of Health (HL098115); National Institutes of Health (UL1 TR000430); National Institutes of Health (UL1TR000150); National Institutes of Health (U10HL098096); National Institutes of Health (UL1 TR000050); National Institutes of Health (HL098075); National Institutes of Health (HL098103); National Institutes of Health (HL098177); National Institutes of Health (HL098112); National Institutes of Health (HL098098); National Institutes of Health (HL098102); National Heart, Lung, and Blood Institute (T32-HL-007317)
Según 25 financiadores declarados.
Publicación
- Publicado
- 2014-05-18 · JAMA · vol. 311 · número 20 · pág. 2083
- Editorial
- American Medical Association
- Citado
- 277 citas · más que el 100% de estudios similares · 29.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 32 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Vitamin D Research Studies · Asthma and respiratory diseases · Adrenal Hormones and Disorders
- Palabras clave
- vitamin D3 supplementation, vitamin D insufficiency, asthma, inhaled corticosteroids, ciclesonide, asthma control, corticosteroid tapering, asthma exacerbations, lung function decline, beta-agonist use, systemic corticosteroid use, health care utilization, adult asthma, 25-hydroxyvitamin D
- MeSH
- lung, humans, asthma, vitamin d deficiency, cholecalciferol, pregnenediones, adrenal cortex hormones, vitamins, anti-asthmatic agents, glucocorticoids, treatment failure, administration, inhalation, administration, oral, double-blind method, dose-response relationship, drug, adult, middle aged, female, male
40 autores
- Mario Castro🇺🇸Washington University in St. Louis
- Tonya Sharp King🇺🇸Pennsylvania State University
- Susan J. Kunselman🇺🇸Pennsylvania State University
- Michael D. Cabana🇺🇸University of California, San Francisco
- Loren C. Denlinger🇺🇸University of Wisconsin–Madison
- Fernando Holguín🇺🇸University of Pittsburgh
- Shamsah D. Kazani🇺🇸Brigham and Women's Hospital; Harvard University
- Wendy C. Moore🇺🇸Wake Forest University Health Sciences; Wake Forest University
- James N. Moy🇺🇸John H. Stroger, Jr. Hospital of Cook County; Cook County Health and Hospitals System
- Christine A. Sorkness🇺🇸University of Wisconsin–Madison
- Pedro C. Avila🇺🇸Northwestern University
- Leonard B. Bacharier🇺🇸Washington University in St. Louis
- Eugene R. Bleecker🇺🇸Wake Forest University Health Sciences; Wake Forest University
- Homer A. Boushey🇺🇸University of California, San Francisco
- James F. Chmiel🇺🇸Rainbow Babies & Children's Hospital
- Anne M. Fitzpatrick🇺🇸Emory University
- Deborah Ann Gentile🇺🇸Allegheny General Hospital
- Mandeep Hundal🇺🇸Duke University
- Elliot Israel🇺🇸Brigham and Women's Hospital; Harvard University
- Monica Kraft🇺🇸Duke University
- Jerry A. Krishnan🇺🇸University of Illinois Chicago
- Craig LaForce🇺🇸North Carolina Clinical Research
- Stephen C. Lazarus🇺🇸University of California, San Francisco
- Robert F. Lemanske🇺🇸University of Wisconsin–Madison
- Njira Lucia Lugogo🇺🇸Duke University
- Richard J. Martin🇺🇸National Jewish Health
- David T. Mauger🇺🇸Pennsylvania State University
- Edward T. Naureckas🇺🇸University of Chicago
- Stephen P. Peters🇺🇸Wake Forest University Health Sciences; Wake Forest University
- Wanda Phipatanakul🇺🇸Boston Children's Hospital; Harvard University
- Loretta G. Que🇺🇸Duke University
- Ajay Sheshadri🇺🇸Washington University in St. Louis
- Lewis J. Smith🇺🇸Northwestern University
- Julian Solway🇺🇸University of Chicago
- Lisa Sullivan-Vedder🇺🇸Aurora Sinai Medical Center
- Kaharu Sumino🇺🇸Washington University in St. Louis
- Michael E. Wechsler🇺🇸National Jewish Health
- Sally E. Wenzel🇺🇸University of Pittsburgh
- Steven R. White🇺🇸University of Chicago
- E. Rand Sutherland🇺🇸National Jewish Health
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency.
Objective
To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels.
Design, setting, and participants
The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014. After a run-in period that included treatment with an inhaled corticosteroid, 408 patients were randomized.
Interventions
Oral vitamin D3 (100,000 IU once, then 4000 IU/d for 28 weeks; n = 201) or placebo (n = 207) was added to inhaled ciclesonide (320 µg/d). If asthma control was achieved after 12 weeks, ciclesonide was tapered to 160 µg/d for 8 weeks, then to 80 µg/d for 8 weeks if asthma control was maintained.
Main outcomes and measures
The primary outcome was time to first asthma treatment failure (a composite outcome of decline in lung function and increases in use of β-agonists, systemic corticosteroids, and health care).
Results
Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks (28% [95% CI, 21%-34%] with vitamin D3 vs 29% [95% CI, 23%-35%] with placebo; adjusted hazard ratio, 0.9 [95% CI, 0.6-1.3]). Of 14 prespecified secondary outcomes, 9 were analyzed, including asthma exacerbation; of those 9, the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control (111.3 µg/d [95% CI, 102.2-120.4 µg/d] in the vitamin D3 group vs 126.2 µg/d [95% CI, 117.2-135.3 µg/d] in the placebo group; difference of 14.9 µg/d [95% CI, 2.1-27.7 µg/d]).
Conclusions and relevance
Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency. These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma.
Trial registration
clinicaltrials.gov Identifier: NCT01248065.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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