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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Vitamin D3
Drug: Ciclesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 408
Study Start Date: April 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ciclesonide + placebo Drug: Ciclesonide
Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
Other Name: Alvesco®
Experimental: Ciclesonide + Vitamin D 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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248065

Locations
United States, California
University of California - San Francisco
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University Medical Center/Stroger Hospital
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27110
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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
  More Information

No publications provided by Milton S. Hershey Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01248065     History of Changes
Other Study ID Numbers: AsthmaNet 001, 1U10HL098115
Study First Received: November 24, 2010
Results First Received: June 18, 2014
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Milton S. Hershey Medical Center:
Asthma
Vitamin D
Corticosteroids
Treatment failure

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Ciclesonide
Ergocalciferols
Vitamin D
Vitamins
Anti-Allergic Agents
Bone Density Conservation Agents
Glucocorticoids
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014