We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial.
- Authors
Castro, Mario; King, Tonya S; Kunselman, Susan J; Cabana, Michael D; Denlinger, Loren; Holguin, Fernando; Kazani, Shamsah D; Moore, Wendy C; Moy, James; Sorkness, Christine A; Avila, Pedro; Bacharier, Leonard B; Bleecker, Eugene; Boushey, Homer A; Chmiel, James; Fitzpatrick, Anne M; Gentile, Deborah; Hundal, Mandeep; Israel, Elliot; Kraft, Monica
- Abstract
<bold>Importance: </bold>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.<bold>Objective: </bold>To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels.<bold>Design, Setting, and Participants: </bold>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.<bold>Interventions: </bold>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.<bold>Main Outcomes and Measures: </bold>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).<bold>Results: </bold>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]).<bold>Conclusions and Relevance: </bold>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.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT01248065.
- Publication
JAMA: Journal of the American Medical Association, 2014, Vol 311, Issue 20, p2083
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2014.5052