Use of Vitamin D3 for the Treatment of Steroid Resistant Asthmatic Patients

• Status: Withdrawn
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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 responsive to the latter form of treatment. Patients will be treated daily with an oral dose (2,000 IU) of vitamin D3 for one month and their clinical and serological parameters, and immune function, will be evaluated. Results from pre- and post-vitaminD3 treatment will be compared.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Florida Atlantic University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria: 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:

1. Treatment with continuous or near continuous (>50% of year) oral corticosteroids

2. Requirement for treatment with high-dose inhaled corticosteroids:

Drug Dose (µg/d) Dose (puffs/d)

1. Beclomethasone dipropionate. > 1,260. > 40 puffs (42 µg /inhalation).

> 20 puffs (84 µg/inhalation)

2. Budesonide > 1,200 > 6 puffs

3. Flunisolide > 2,000 > 8 puffs

4. Fluticasone propionate > 880 > 8 puffs(110µg), >4puffs(220 µg)

5. Triamcinolone acetonide > 2,000 > 20 puffs

Minor Characteristics

1. Requirement for daily treatment with a controller medication in addition to inhaled corticosteroids, e.g., long-acting β-agonist, theophylline, or leukotriene antagonist

2. Asthma symptoms requiring short-acting β-agonist use on a daily or near daily basis

3. Persistent airway obstruction (FEV1,80% predicted; diurnal PEF variability >20%)

4. One or more urgent care visits for asthma per year

5. Three or more oral steroid "bursts" per year

6. Prompt deterioration with<25% reduction in oral or inhaled corticosteroid dose

7. Near fatal asthma event in the past Additional minor characteristics include : normal diffusing capacity and methacholine PC20 be less than 8mg.

Exclusion Criteria: 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.