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

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® |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
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 |
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 |
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 |
Asthma Vitamin D Corticosteroids Treatment failure |
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 Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Allergic Agents |