Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Cholecalciferol; Ciclesonide; Ergocalciferols; Vitamin D; Vitamins

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)