Vitamin D to Prevent Severe Asthma Exacerbations (Vit-D-Kids Asthma)
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|ClinicalTrials.gov Identifier: NCT02687815|
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: vitamin D3 4000 IU Drug: Placebo||Phase 2|
Results from experimental studies, observational studies, two small trials, and a recent meta-analysis 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 16 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.
Study participation involves 8-9 visits, with each visit lasting between 30-90 minutes. Participation requires completion of study questionnaires, spirometry (breathing tests), and collection of blood samples (to measure vitamin D levels) and urine samples (to measure urinary calcium/creatinine ratios) at some study visits. Since the start of the study, vitamin D levels and urinary calcium/creatinine ratios have been simultaneously measured, to monitor for both vitamin D toxicity and high risk of severe vitamin D deficiency or rickets, which (should they occur) would be managed by a pediatric endocrinologist or a pediatric nephrologist, as appropriate.
All safety data for the study is regularly reviewed by a Data Safety Monitoring Board appointed by the National Heart, Lung and Blood Institute, as well as by the Institutional Review Board of each participating institution. Total study participation will last about one year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vitamin D to Prevent Severe Asthma Exacerbations|
|Actual Study Start Date :||February 22, 2016|
|Actual Primary Completion Date :||September 2019|
|Actual Study Completion Date :||September 2019|
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.
- Severe asthma exacerbations [ Time Frame: 48 weeks ]
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 ]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 ]
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687815
|United States, California|
|University of California - San Francisco|
|San Francisco, California, United States, 94102|
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Saint Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Juan C. Celedón, MD, DrPH||University of Pittsburgh|
|Principal Investigator:||Stephen Wisniewski, PhD||University of Pittsburgh|