Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Vitamin D3; Ciclesonide
Intervention description: vitamin D (100,000 IU loading dose followed by 4,000 IU/day); Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
Intervention MeSH terms: Vitamin D; Cholecalciferol; Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 408.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; Vitamin D; Corticosteroids; Treatment failure

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.
    

Eligibility 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)