Vitamin D to Prevent Severe Asthma Exacerbations (Vit-D-Kids Asthma)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Vitamin D to Prevent Severe Asthma Exacerbations|
- Severe asthma exacerbations [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
A severe asthma exacerbation is defined as an exacerbation that meets either of these criteria: 1) Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days OR
2) A hospitalization or ER visit because of asthma, requiring systemic corticosteroids.
- Severe asthma exacerbations resulting from viral infections [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]A severe viral asthma exacerbation is defined as a severe asthma exacerbation (defined above) along with a positive respiratory viral panel from a nasal blow collected within 72 hours of the exacerbation.
- Reduction in ICS dose at visit 6 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
In the absence of moderate or severe asthma exacerbations, participants may have their dose of ICS reduced by 50% if the following criteria are met at visit 6 (halfway through the Trial Phase):
- ACT score greater than 19
- Both pre-bronchodilator FEV1 and FEV1/FVC ≥80% of predicted
- Use of ≤4 puffs of a rescue inhaler per week
- ≤1 day per month with asthma symptoms preventing full participation in usual daily activities
- Clinician's judgment regarding adequate asthma control
- Average cumulative prescribed dose of ICS at the end of the trial [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2016|
|Estimated Study Completion Date:||September 2019|
|Estimated Primary Completion Date:||September 2019 (Final data collection date for primary outcome measure)|
Experimental: vitamin D3
Cholecalciferol (Vitamin D3) 4000 IU oral gel cap daily
Drug: vitamin D3 4000 IU
The vitamin D3 will be in oral gel cap form and contain 4000 International Units (IU) of cholecalciferol per gel cap.
Other Name: Cholecalciferol
Placebo Comparator: placebo
placebo formulations will be in gel cap form and identical to the active drug
The placebo is a gel cap that is indistinguishable from the vitamin D3 gel cap.
Results from experimental studies, observational studies, and two small trials suggest that vitamin D reduces the risk of severe asthma exacerbations, and that this protective effect may be due to immune modulation of viral illnesses and/or increased response to inhaled corticosteroids (ICS).
On the basis of those findings, the investigators hypothesize that vitamin D reduces the incidence of severe asthma exacerbations in high-risk school-aged children who have a serum vitamin D level <30 ng/ml and who are being treated with ICS for persistent asthma. The investigators further hypothesize that this protective effect results from reduced incidence of common viral illnesses or enhanced response to ICS. These hypotheses will be tested in a 48-week randomized double-masked placebo-controlled trial of vitamin D3 supplementation to prevent severe asthma exacerbations in 400 children aged 6 to 14 years who have vitamin D insufficiency or deficiency (a serum 25(OH)D <30 ng/ml) and experienced a severe exacerbation in the prior year (a marker of high risk for subsequent events), and who (after a run-in period) are well controlled on medium-dose inhaled corticosteroids.
Our primary aim will determine whether vitamin D3 (4,000 IU/day) reduces the risk of severe asthma exacerbations (our primary outcome) in participating children. Secondary aims will determine the efficacy of vitamin D3 supplementation in: 1) preventing severe asthma exacerbations due to viral infections, 2) reducing the daily and average cumulative dose of inhaled corticosteroids.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02687815
|Contact: Elizabeth Hartigan, RNfirstname.lastname@example.org|
|Contact: Cynthia Grannyemail@example.com|
|United States, California|
|University of California - San Francisco||Recruiting|
|San Francisco, California, United States, 94102|
|Principal Investigator: Michael Cabana|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator: Juan C Celedon, MD, DrPH|
|Principal Investigator:||Juan C. Celedón, MD, DrPH||University of Pittsburgh|
|Principal Investigator:||Stephen Wisniewski, PhD||University of Pittsburgh|