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Trial record 1 of 3 for:    VIDA asthma
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Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma (VIDA)

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ClinicalTrials.gov Identifier: NCT01248065
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE November 24, 2010
First Posted Date  ICMJE November 25, 2010
Results First Submitted Date  ICMJE June 18, 2014
Results First Posted Date  ICMJE August 13, 2014
Last Update Posted Date August 13, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
Treatment Failure [ Time Frame: Twenty-eight week intervention period from randomization until end of trial. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2010)
Treatment Failure [ Time Frame: Twenty-eight week intervention period from randomization until end of trial. ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
  • Lung Function Change From Baseline [ Time Frame: Change is measured as value at 28 weeks minus baseline value. ]
    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 ]
    Outcome defined as number of exacerbations per person-year.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2010)
Lung function [ Time Frame: At each study visit. ]
FEV1 (liters and % predicted), maximum percent response to bronchodilator (180-360 mcg levalbuterol) and airway hyperresponsiveness as measured by methacholine PC20 will be evaluated.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma
Official Title  ICMJE Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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®
Study Arms  ICMJE
  • Placebo Comparator: Ciclesonide + placebo
    Intervention: Drug: Ciclesonide
  • Experimental: Ciclesonide + Vitamin D
    Interventions:
    • Drug: Vitamin D3
    • Drug: Ciclesonide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2014)
408
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2010)
400
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01248065
Other Study ID Numbers  ICMJE AsthmaNet 001
1U10HL098115 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party dave mauger, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
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 Medical Center
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 University Health Sciences
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
PRS Account Milton S. Hershey Medical Center
Verification Date July 2014

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