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JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.

Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial.

Author information

1
Washington University School of Medicine, St Louis, Missouri.
2
Penn State University, Hershey, Pennsylvania.
3
University of California, San Francisco.
4
University of Wisconsin, Madison.
5
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
6
Brigham and Women's Hospital, Boston, Massachusetts.
7
Wake Forest School of Medicine, Winston-Salem, North Carolina.
8
Stroger Hospital of Cook County, Chicago, Illinois.
9
Northwestern University, Chicago, Illinois.
10
Rainbow Babies and Children's Hospital, Cleveland, Ohio.
11
Emory University, Atlanta, Georgia.
12
Allegheny General Hospital, Pittsburgh, Pennsylvania.
13
Duke University School of Medicine, Durham, North Carolina.
14
University of Illinois, Chicago.
15
North Carolina Clinical Research, Raleigh.
16
National Jewish Health, Denver, Colorado.
17
University of Chicago, Chicago, Illinois.
18
Boston Children's Hospital, Boston, Massachusetts.
19
Aurora Sinai Medical Center, Milwaukee, Wisconsin.
20
National Jewish Health, Denver, Colorado20Dr Sutherland is now with sanofi.

Abstract

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.

PMID:
24838406
PMCID:
PMC4217655
DOI:
10.1001/jama.2014.5052
[Indexed for MEDLINE]
Free PMC Article

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