Vitamin D, Steroids, and Asthma in African American Youth

Asthma Clinical Trial

— AsthMaP2  

Official title:

AsthMaP 2: Vitamin D, Steroids, and Asthma in African American Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647399
• Other study ID #: R01MD007075-01
• Status: Completed
• Start date: July 2012
• Est. completion date: July 2018

Study information

• Verified date: March 2019
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Asthma has become considerably more prevalent and severe in the U.S. during the last 40 years, particularly affecting youth in urban areas, yet the reasons for this are not clear. There is increasing evidence that vitamin D insufficiency contributes to more severe asthma through increased risk of respiratory infections and decreased sensitivity to glucocorticoids. Indeed, low vitamin D levels are linked with the need for exogenous glucocorticoids and increased asthma severity. Particularly relevant to health disparities, we showed a strong association between vitamin D insufficiency and asthma in urban African American (AA) youth. Importantly, AA youth in ours and other studies had lower vitamin D levels than non-AA participants.

Because AA youth residing in urban Washington, DC have markedly worse asthma than other racial/ethnic groups (e.g. prevalence rate 20% higher than the national rate 15 and emergency department utilization rates up to 5 times the national rates and nearly 10 times the Healthy People 2010 target rate), we will utilize our access to this population at the extreme of asthma disparities to examine the contribution of vitamin D to disparities in the chronic control and acute severity of asthma. The overall goal of this study is to provide critical epidemiological/molecular information that will inform the interpretation of ongoing and impending randomized clinical trials of vitamin D supplementation in asthma, especially with regard to urban AA youth with asthma. We hypothesize that low serum 25-hydroxyvitamin D [25(OH)D] levels are associated with poor chronic asthma control, worse acute asthma severity, and glucocorticoid insensitivity. The knowledge generated by the experiments in this application will be crucial to translation of this inexpensive, easily-accessible, and thereby potentially disparity-reducing prospective therapy for asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: July 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

Inclusion Criteria:

• Between 6 and 20 years of age

• Physician-diagnosed asthma for 1 year or more

• Caretaker/Independent participant willing to sign the written Informed Consent, Assent form when appropriate

Exclusion Criteria:

• Significant, chronic medical illnesses other than asthma

• No access to a phone

Related Conditions & MeSH terms

• Allergy
• Asthma

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Robert J. Freishtat

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25(OH)D measurement by liquid chromatography-tandem mass spectrometry		one year

External Links

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