Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma
- Registration Number
- NCT01248065
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 408
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ciclesonide + placebo Ciclesonide - Ciclesonide + Vitamin D Vitamin D3 - Ciclesonide + Vitamin D Ciclesonide -
- Primary Outcome Measures
Name Time Method Treatment Failure 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
Name Time Method Exacerbations Overall exacerbation rate during 28-week trial Outcome defined as number of exacerbations per person-year.
Lung Function Change From Baseline 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.
Trial Locations
- Locations (16)
Emory University
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center/Stroger Hospital
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Aurora Sinai Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States