Phase 3
Completed N=408
Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma
Source: ClinicalTrials.gov NCT01248065 ↗Enrolled (actual)
408
Serious AEs
3.7%
Results posted
Aug 2014
Primary outcomePrimary: Treatment Failure — 29; 28 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Failure |
29; 28 | — |
| SECONDARY Lung Function Change From Baseline |
-0.04; -0.07 | — |
| SECONDARY Exacerbations |
0.40; 0.26 | — |
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 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)
Data sourced from ClinicalTrials.gov (NCT01248065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.