Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01248065
First received: November 24, 2010
Last updated: July 23, 2014
Last verified: July 2014

November 24, 2010
July 23, 2014
April 2011
January 2014   (final data collection date for primary outcome measure)
Treatment Failure [ Time Frame: Twenty-eight week intervention period from randomization until end of trial. ] [ Designated as safety issue: No ]
Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.
Treatment failure [ Time Frame: Twenty-eight week intervention period from randomization until end of trial. ] [ Designated as safety issue: No ]
Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the ATS/ERS definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more.
Complete list of historical versions of study NCT01248065 on ClinicalTrials.gov Archive Site
  • Lung Function Change From Baseline [ Time Frame: Change is measured as value at 28 weeks minus baseline value. ] [ Designated as safety issue: No ]
    FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline.
  • Exacerbations [ Time Frame: Overall exacerbation rate during 28-week trial ] [ Designated as safety issue: No ]
    Outcome defined as number of exacerbations per person-year.
Lung function [ Time Frame: At each study visit. ] [ Designated as safety issue: No ]
FEV1 (liters and % predicted), maximum percent response to bronchodilator (180-360 mcg levalbuterol) and airway hyperresponsiveness as measured by methacholine PC20 will be evaluated.
Not Provided
Not Provided
 
Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma
Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Vitamin D3
    vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
  • Drug: Ciclesonide
    Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
    Other Name: Alvesco®
  • Placebo Comparator: Ciclesonide + placebo
    Intervention: Drug: Ciclesonide
  • Experimental: Ciclesonide + Vitamin D
    Interventions:
    • Drug: Vitamin D3
    • Drug: Ciclesonide
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 28;311(20):2083-91. doi: 10.1001/jama.2014.5052.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
408
January 2014
January 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01248065
AsthmaNet 001, 1U10HL098115
Yes
dave mauger, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: David T. Mauger, PhD Pennsylvania State University College of Medicine
Principal Investigator: Elliot Israel, MD Brigham and Women's Hospital
Principal Investigator: Lewis Smith, MD Northwestern Memorial Hospital
Principal Investigator: Julian Solway, MD University of Chicago
Principal Investigator: James Moy, MD Rush University Medical Center
Principal Investigator: Richard Martin, MD National Jewish Health
Principal Investigator: Christine Sorkness, MD University of Wisconsin, Madison
Principal Investigator: Elizabeth Bade, MD Aurora Sinai Medical Center
Principal Investigator: Sally Wenzel, MD University of Pittsburgh
Principal Investigator: James Chmiel, MD Case Western Reserve University School of Medicine
Principal Investigator: Mario Castro, MD Washington University School of Medicine
Principal Investigator: Homer Boushey, MD University of California, San Francisco
Principal Investigator: Monica Kraft, MD Duke University
Principal Investigator: Stephen Peters, MD Wake Forest School of Medicine
Principal Investigator: W. Gerald Teague, MD University of Virginia Health System
Principal Investigator: Craig LaForce, MD North Carolina Clinical Research
Principal Investigator: Anne Fitzpatrick, MD Emory University
Principal Investigator: Jerry Krishnan, MD University of Illinois at Chicago
Milton S. Hershey Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP