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Original Investigation |

Effect of Vitamin D3 on Asthma Treatment Failures in Adults With Symptomatic Asthma and Lower Vitamin D Levels:  The VIDA Randomized Clinical Trial

Mario Castro, MD, MPH1; Tonya S. King, PhD2; Susan J. Kunselman, MA2; Michael D. Cabana, MD, MPH3; Loren Denlinger, MD, PhD4; Fernando Holguin, MD5; Shamsah D. Kazani, MD6; Wendy C. Moore, MD7; James Moy, MD8; Christine A. Sorkness, PharmD4; Pedro Avila, MD9; Leonard B. Bacharier, MD1; Eugene Bleecker, MD7; Homer A. Boushey, MD3; James Chmiel, MD10; Anne M. Fitzpatrick, PhD11; Deborah Gentile, MD12; Mandeep Hundal, MD13; Elliot Israel, MD6; Monica Kraft, MD13; Jerry A. Krishnan, MD, PhD14; Craig LaForce, MD15; Stephen C. Lazarus, MD3; Robert Lemanske, MD4; Njira Lugogo, MD13; Richard J. Martin, MD16; David T. Mauger, PhD2; Edward Naureckas, MD17; Stephen P. Peters, MD, PhD7; Wanda Phipatanakul, MD, MS18; Loretta G. Que, MD13; Ajay Sheshadri, MD1; Lewis Smith, MD9; Julian Solway, MD17; Lisa Sullivan-Vedder, MD19; Kaharu Sumino, MD, MPH1; Michael E. Wechsler, MD16; Sally Wenzel, MD5; Steven R. White, MD17; E. Rand Sutherland, MD, MPH16,20 ; for the National Heart, Lung, and Blood Institute’s AsthmaNet
[+] Author Affiliations
1Washington University School of Medicine, St Louis, Missouri
2Penn State University, Hershey, Pennsylvania
3University of California, San Francisco
4University of Wisconsin, Madison
5University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
6Brigham and Women’s Hospital, Boston, Massachusetts
7Wake Forest School of Medicine, Winston-Salem, North Carolina
8Stroger Hospital of Cook County, Chicago, Illinois
9Northwestern University, Chicago, Illinois
10Rainbow Babies and Children’s Hospital, Cleveland, Ohio
11Emory University, Atlanta, Georgia
12Allegheny General Hospital, Pittsburgh, Pennsylvania
13Duke University School of Medicine, Durham, North Carolina
14University of Illinois, Chicago
15North Carolina Clinical Research, Raleigh
16National Jewish Health, Denver, Colorado
17University of Chicago, Chicago, Illinois
18Boston Children’s Hospital, Boston, Massachusetts
19Aurora Sinai Medical Center, Milwaukee, Wisconsin
20Dr Sutherland is now with sanofi.
JAMA. 2014;311(20):2083-2091. doi:10.1001/jama.2014.5052.
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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

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Figure 1.
Participant Flow of VIDA Trial

VIDA indicates Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma. Postrandomization dropouts were included in the analysis as censored observations.aDetails for those screened but ineligible were not collected.bThe most common reasons were predicted forced expiratory volume in the first second of expiration (FEV1) greater than 90% (n = 286; a subsequent protocol modification removed this criteria), did not have a provocative concentration of methacholine at which FEV1 decreased by 20% or did not qualify for challenge (n = 60), too few symptoms (n = 52), and predicted FEV1 of less than 50% (n = 41).

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Figure 2.
Primary Treatment Failure Outcome

Vertical bars represent censored events. The adjusted hazard ratio for time from randomization to first treatment failure was 0.9 (95% CI, 0.6-1.3) for the vitamin D3 vs placebo treatment groups (P = .54).

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Figure 3.
Secondary Exacerbation Outcome

The first data point corresponds to the number of exacerbations that occurred during the first 4 weeks of treatment. The adjusted hazard ratio for cumulative number of exacerbations that occurred over the course of the trial was 0.63 (95% CI, 0.39-1.01; P = .05).

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