Asthma Attacks and Vitamin D Deficiency – Phase II

Boy using an asthma inhaler

Vitamin D to Prevent Severe Asthma Exacerbations (Vit-D-Kids Asthma)

Protocol Description

Vit-D-Kids Asthma Study LogoThis study will determine whether vitamin D3 helps to prevent severe asthma attacks in asthmatic children who are being treated with inhaled corticosteroids. Results from prior studies suggest that vitamin D reduces the risk of severe asthma attacks and that this protective effect may be due to immune modulation of viral illnesses or increased response to inhaled corticosteroids. This research will focus on high-risk school-aged children who have vitamin D insufficiency or deficiency. See study overview video.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting patients of both genders, ages 6 to 14 years, who have asthma as well as vitamin D insufficiency, and who have had at least one severe asthma attack in the prior year.
Males and Females: Ages 6 to 14 years

Requirements

In the first 5 weeks candidates will have 3 study visits for exams and testing. Those eligible to continue in the study will be randomly selected to receive either a daily dose of vitamin D3 or a placebo to be taken orally for the duration of the study. Participants will have 6 additional study visits for exams and testing over the next 48 weeks of the study.
Visits: 9
Duration: About a year

Status: Open to Enrollment

Source(s) of Support

Pharmavite
National Heart, Lung, and Blood Institute, National Institutes of Health

Primary Investigator

Juan C. Celedón, MD, PhD

Contact Information

For more information about the study or enrollment, please contact:
Cynthia Granny or Pamela Vincent, Research Coordinators
877-296-9026