Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01921894
Eligibility Criteria:
Inclusion Criteria:
* Be at least 6 years of age and younger than 15 years of age
* Have physician-diagnosed asthma
* Taking a medium dose of ICS (e.g. fluticasone 220mcg BID) for daily asthma control for at least 6 months in the prior year.
* Have had a severe asthma exacerbation in the previous year, defined as an Emergency Department (ED) visit, hospitalization, or unscheduled clinic visit for asthma resulting in intramuscular, intravenous, or oral steroids.
* Have bronchodilator responsiveness (BDR, an increase in FEV1 ≥12% from baseline after administration of inhaled albuterol) or (if no BDR) increased airway responsiveness to methacholine challenge
* Have vitamin D insufficiency (a serum vitamin D (25(OH)D) level \<30 ng/ml)
* Have his/her parents give voluntary written consent to participate in the study
Exclusion Criteria:
* Chronic respiratory disorder other than asthma (e.g., bronchiectasis).
* Severe asthma, as evidenced by any of the following: a) chronic need for medication other than single controller therapy and inhaled β2-agonist, b) intubation for asthma at any time, and c) ≥2 hospitalizations or ≥6 severe asthma exacerbations in the previous year
* History of cigarette smoking in the prior year or former smoking if ≥5 pack-years
* Hepatic or renal disease, metabolic rickets, malabsorptive disorders, or other chronic diseases that would affect vitamin D metabolism
* Immune deficiency, cleft palate or Down's syndrome, which might increase the child's likelihood of respiratory infections
* Treatment with anticonvulsants or pharmacological doses of vitamin D (≥1,000 IU/day of vitamin D2 or D3)
* Chronic oral corticosteroid therapy
* Inability to perform acceptable spirometry
* Use of investigational therapies or participation in clinical trials 30 days before or during the duration of the study
* Serum calcium \>10.8 mg/dl
* Serum 25(OH) D \<10 ng/ml (severe vitamin D deficiency)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT01921894
Study Brief:
Protocol Section:
NCT01921894