Status:
COMPLETED
Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Parti...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT01248065
Start Date
April 1 2011
End Date
January 1 2014
Last Update
August 13 2014
Active Locations (16)
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1
University of California - San Francisco
San Francisco, California, United States, 94143
2
National Jewish Health
Denver, Colorado, United States, 80206
3
Emory University
Atlanta, Georgia, United States, 30322
4
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611