Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Vitamin D3 Drug: Ciclesonide Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma
Study Start Date : April 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Exacerbations [ Time Frame: Overall exacerbation rate during 28-week trial ]
    Outcome defined as number of exacerbations per person-year.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248065


Locations
Layout table for location information
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
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
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
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
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01248065    
Other Study ID Numbers: AsthmaNet 001
1U10HL098115 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2010    Key Record Dates
Results First Posted: August 13, 2014
Last Update Posted: August 13, 2014
Last Verified: July 2014
Keywords provided by dave mauger, Milton S. Hershey Medical Center:
Asthma
Vitamin D
Corticosteroids
Treatment failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamin D
Cholecalciferol
Ciclesonide
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents