Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma

NCT ID: NCT01248065

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of the study is to find out if taking vitamin D in addition to an asthma controller medication helps to prevent worsening of asthma symptoms and asthma attacks.

Detailed Description

This is a randomized, double-blind parallel group trial that will enroll individuals who have vitamin D insufficiency and asthma with persistent symptoms despite low-dose inhaled corticosteroid. Participants on low-dose inhaled corticosteroid will be randomized to add-on therapy with either placebo or high-dose vitamin D for a 28-week period. During the inhaled corticosteroid-stable phase, participants will remain on low-dose inhaled corticosteroid. During the inhaled corticosteroid-taper phase, participants will taper their inhaled corticosteroid by 50% at two time-points post-randomization. The investigators will determine if the addition of vitamin D reduces the likelihood of treatment failure when compared to placebo during both the inhaled corticosteroid-stable and inhaled corticosteroid-taper phases of the study. Given the high prevalence of both vitamin D insufficiency and asthma, this trial has high potential to impact daily asthma management.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ciclesonide + placebo

Group Type: PLACEBO_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

Ciclesonide + Vitamin D

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

vitamin D (100,000 IU loading dose followed by 4,000 IU/day)

Ciclesonide

Intervention Type: DRUG

Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

Interventions

Vitamin D3

vitamin D (100,000 IU loading dose followed by 4,000 IU/day)

Intervention Type: DRUG

Ciclesonide

Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

Intervention Type: DRUG

Other Intervention Names

Alvesco®

Eligibility Criteria

Inclusion Criteria

• Men and women 18 years of age and older
• Physician-diagnosed asthma for at least previous 12 months
• Asthma confirmed by: (a) β-agonist reversibility of forced expiratory volume in 1 second (FEV1) ≥12 % following 180 mcg (4 puffs) levalbuterol at visit 1 OR (b) methacholine provocative concentration causing a 20% fall in FEV1 (PC20) ≤ 8 mg/ml if not receiving an inhaled corticosteroid or ≤ 16 mg/ml if receiving an inhaled corticosteroid at visit 2. Source documentation for PC20 from an AsthmaNet methacholine challenge completed within 6 months of visit 2 will be accepted.
• Stable asthma controller therapy (inhaled corticosteroid or leukotriene modifier only) dose for past 2 weeks
• FEV1 ≥ 50% of predicted at visit 1
• Vitamin D level of less than 30 ng/ml at visit 0
• Experienced no more than one treatment failure in the VIDA run-in or oral corticosteroid (OCS) response periods on previous enrollments
• For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method for the duration of the study

Exclusion Criteria

• Taking vitamin D supplements containing > 1000 IU/day of vitamin D
• Taking >2500 mg/day calcium supplements
• Chronic oral corticosteroid therapy
• Chronic inhaled corticosteroid therapy > 1,000 mcg of fluticasone daily or the equivalent
• History of physician-diagnosed nephrolithiasis
• Use of concomitant medications that alter vitamin D metabolism - phenytoin, phenobarbital, cardiac glycosides; or absorption - orlistat, cholestyramine, colestipol; or those that interfere with study endpoints
• Impaired renal function (GFR < 30 ml/min)
• Asthma exacerbation within past 4 weeks requiring systemic corticosteroids
• Respiratory tract infection within past 4 weeks
• Chronic diseases (other than asthma)
• History of cigarette smoking within the past 1 year or > 10 pack years total
• Serum calcium greater than 10.2 mg/dl on entry
• Urine calcium/creatinine ratio greater than 0.37 (urinary Ca and Creat in mg)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

dave mauger

Principal Investigator, AsthmaNet Data Coordinating Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David T. Mauger, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennsylvania State University College of Medicine

Elliot Israel, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Lewis Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Memorial Hospital

Julian Solway, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

James Moy, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Richard Martin, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Christine Sorkness, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Elizabeth Bade, MD

Role: PRINCIPAL_INVESTIGATOR

Aurora Sinai Medical Center

Sally Wenzel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

James Chmiel, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University School of Medicine

Mario Castro, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Homer Boushey, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Monica Kraft, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Stephen Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

W. Gerald Teague, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Craig LaForce, MD

Role: PRINCIPAL_INVESTIGATOR

North Carolina Clinical Research

Anne Fitzpatrick, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Jerry Krishnan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of California - San Francisco

San Francisco, California, United States

National Jewish Health

Denver, Colorado, United States

Emory University

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Rush University Medical Center/Stroger Hospital

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Duke University School of Medicine

Durham, North Carolina, United States

North Carolina Clinical Research

Raleigh, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Jiao J, King TS, McKenzie M, Bacharier LB, Dixon AE, Codispoti CD, Dunn RM, Grossman NL, Lugogo NL, Ramratnam SK, Traister RS, Wechsler ME, Castro M; National Heart, Lung, and Blood Institute's AsthmaNet. Vitamin D3 therapy in patients with asthma complicated by sinonasal disease: Secondary analysis of the Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma trial. J Allergy Clin Immunol. 2016 Aug;138(2):589-592.e2. doi: 10.1016/j.jaci.2015.12.1329. Epub 2016 Mar 11. No abstract available.

Reference Type: DERIVED

PMID: 26971692 (View on PubMed)

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

Reference Type: DERIVED

PMID: 24838406 (View on PubMed)

Other Identifiers

1U10HL098115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AsthmaNet 001

Identifier Type: -

Identifier Source: org_study_id