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

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.

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  • Authors+Show Affiliations

    ,

    Washington University School of Medicine, St Louis, Missouri.

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    Penn State University, Hershey, Pennsylvania.

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    Penn State University, Hershey, Pennsylvania.

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    University of California, San Francisco.

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    University of Wisconsin, Madison.

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    University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

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    Brigham and Women's Hospital, Boston, Massachusetts.

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    Wake Forest School of Medicine, Winston-Salem, North Carolina.

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    Stroger Hospital of Cook County, Chicago, Illinois.

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    University of Wisconsin, Madison.

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    Northwestern University, Chicago, Illinois.

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    Washington University School of Medicine, St Louis, Missouri.

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    Wake Forest School of Medicine, Winston-Salem, North Carolina.

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    University of California, San Francisco.

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    Rainbow Babies and Children's Hospital, Cleveland, Ohio.

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    Emory University, Atlanta, Georgia.

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    Allegheny General Hospital, Pittsburgh, Pennsylvania.

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    Duke University School of Medicine, Durham, North Carolina.

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    Brigham and Women's Hospital, Boston, Massachusetts.

    ,

    Duke University School of Medicine, Durham, North Carolina.

    ,

    University of Illinois, Chicago.

    ,

    North Carolina Clinical Research, Raleigh.

    ,

    University of California, San Francisco.

    ,

    University of Wisconsin, Madison.

    ,

    Duke University School of Medicine, Durham, North Carolina.

    ,

    National Jewish Health, Denver, Colorado.

    ,

    Penn State University, Hershey, Pennsylvania.

    ,

    University of Chicago, Chicago, Illinois.

    ,

    Wake Forest School of Medicine, Winston-Salem, North Carolina.

    ,

    Boston Children's Hospital, Boston, Massachusetts.

    ,

    Duke University School of Medicine, Durham, North Carolina.

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    Washington University School of Medicine, St Louis, Missouri.

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    Northwestern University, Chicago, Illinois.

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    University of Chicago, Chicago, Illinois.

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    Aurora Sinai Medical Center, Milwaukee, Wisconsin.

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    Washington University School of Medicine, St Louis, Missouri.

    ,

    National Jewish Health, Denver, Colorado.

    ,

    University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

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    University of Chicago, Chicago, Illinois.

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    National Jewish Health, Denver, Colorado20Dr Sutherland is now with sanofi.

    Source

    JAMA 311:20 2014 May pg 2083-91

    MeSH

    Administration, Inhalation
    Administration, Oral
    Adrenal Cortex Hormones
    Adult
    Anti-Asthmatic Agents
    Asthma
    Cholecalciferol
    Dose-Response Relationship, Drug
    Double-Blind Method
    Female
    Glucocorticoids
    Humans
    Lung
    Male
    Middle Aged
    Pregnenediones
    Treatment Failure
    Vitamin D Deficiency
    Vitamins

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    24838406

    Citation

    Castro, Mario, et al. "Effect of Vitamin D3 On Asthma Treatment Failures in Adults With Symptomatic Asthma and Lower Vitamin D Levels: the VIDA Randomized Clinical Trial." JAMA, vol. 311, no. 20, 2014, pp. 2083-91.
    Castro M, King TS, Kunselman SJ, et al. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA. 2014;311(20):2083-91.
    Castro, M., King, T. S., Kunselman, S. J., Cabana, M. D., Denlinger, L., Holguin, F., ... Sutherland, E. R. (2014). Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA, 311(20), pp. 2083-91. doi:10.1001/jama.2014.5052.
    Castro M, et al. Effect of Vitamin D3 On Asthma Treatment Failures in Adults With Symptomatic Asthma and Lower Vitamin D Levels: the VIDA Randomized Clinical Trial. JAMA. 2014;311(20):2083-91. PubMed PMID: 24838406.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. AU - Castro,Mario, AU - King,Tonya S, AU - Kunselman,Susan J, AU - Cabana,Michael D, AU - Denlinger,Loren, AU - Holguin,Fernando, AU - Kazani,Shamsah D, AU - Moore,Wendy C, AU - Moy,James, AU - Sorkness,Christine A, AU - Avila,Pedro, AU - Bacharier,Leonard B, AU - Bleecker,Eugene, AU - Boushey,Homer A, AU - Chmiel,James, AU - Fitzpatrick,Anne M, AU - Gentile,Deborah, AU - Hundal,Mandeep, AU - Israel,Elliot, AU - Kraft,Monica, AU - Krishnan,Jerry A, AU - LaForce,Craig, AU - Lazarus,Stephen C, AU - Lemanske,Robert, AU - Lugogo,Njira, AU - Martin,Richard J, AU - Mauger,David T, AU - Naureckas,Edward, AU - Peters,Stephen P, AU - Phipatanakul,Wanda, AU - Que,Loretta G, AU - Sheshadri,Ajay, AU - Smith,Lewis, AU - Solway,Julian, AU - Sullivan-Vedder,Lisa, AU - Sumino,Kaharu, AU - Wechsler,Michael E, AU - Wenzel,Sally, AU - White,Steven R, AU - Sutherland,E Rand, AU - ,, PY - 2014/5/20/entrez PY - 2014/5/20/pubmed PY - 2014/8/2/medline SP - 2083 EP - 91 JF - JAMA JO - JAMA VL - 311 IS - 20 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/24838406/Effect_of_vitamin_D3_on_asthma_treatment_failures_in_adults_with_symptomatic_asthma_and_lower_vitamin_D_levels:_the_VIDA_randomized_clinical_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2014.5052 DB - PRIME DP - Unbound Medicine ER -