Status:
WITHDRAWN
Use of Vitamin D3 for the Treatment of Steroid Resistant Asthmatic Patients
Lead Sponsor:
Florida Atlantic University
Conditions:
Asthma
Eligibility:
All Genders
12-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects of vitamin D3 on severe asthmatic patients. Vitamin D3 may alter the response of these patients to conventional steroid therapy, making them more ...
Detailed Description
Asthma is one of the most common chronic diseases in childhood and one of the leading causes of morbidity in children. Its incidence has been growing, especially in the Western, highly industrialized ...
Eligibility Criteria
Inclusion
- Diagnosis of severe steroid resistant asthmatic as defined by the American Thoracic Society workshop 2000. Patients must have been diagnosed for at least one year prior to the study. Patients must exhibit one or more major criteria and two minor criteria from the following list to be included in the study:
- Definition of Severe Asthma by American Thoracic Society Consensus (2000). Major Characteristics
- In order to achieve control to a level of mild-moderate persistent asthma:
- Treatment with continuous or near continuous (\>50% of year) oral corticosteroids
- Requirement for treatment with high-dose inhaled corticosteroids:
- Drug Dose (µg/d) Dose (puffs/d)
- Beclomethasone dipropionate. \> 1,260. \> 40 puffs (42 µg /inhalation).
- \> 20 puffs (84 µg/inhalation)
- Budesonide \> 1,200 \> 6 puffs
- Flunisolide \> 2,000 \> 8 puffs
- Fluticasone propionate \> 880 \> 8 puffs(110µg), \>4puffs(220 µg)
- Triamcinolone acetonide \> 2,000 \> 20 puffs
- Minor Characteristics
- Requirement for daily treatment with a controller medication in addition to inhaled corticosteroids, e.g., long-acting β-agonist, theophylline, or leukotriene antagonist
- Asthma symptoms requiring short-acting β-agonist use on a daily or near daily basis
- Persistent airway obstruction (FEV1,80% predicted; diurnal PEF variability \>20%)
- One or more urgent care visits for asthma per year
- Three or more oral steroid "bursts" per year
- Prompt deterioration with\<25% reduction in oral or inhaled corticosteroid dose
- Near fatal asthma event in the past Additional minor characteristics include : normal diffusing capacity and methacholine PC20 be less than 8mg.
Exclusion
- Patients diagnosed with the following conditions will be excluded:
- Vitamin D resistant rickets, chronic renal failure, hypercalcemia (secondary to hyperparathyroidism or malignancy), Chronic Obstructive Pulmonary Disease, severe malabsorption syndrome, sarcoidosis, patients taking cardiac glycosides for cardiac arrythmias.
- Pregnant or nursing women, and smoking patients will be excluded.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01210521
Start Date
September 1 2010
End Date
February 1 2016
Last Update
August 10 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.