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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01248065

Run by

Milton S. Hershey Medical Center

People needed

408

Starts

2011-04-01

Expected to finish

2014-01-01

Last updated by the study team

2014-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of California - San Francisco — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Rush University Medical Center/Stroger Hospital — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States
• Aurora Sinai Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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