Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma (VIDA)
This study has been completed.
Sponsor:
Milton S. Hershey Medical Center
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
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
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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 (Adult, Senior) |
| 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
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 | |
| 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
| 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
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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Vitamins Vitamin D |
Ergocalciferols Cholecalciferol Ciclesonide Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Allergic Agents |
ClinicalTrials.gov processed this record on September 29, 2016