Vitamin D, Steroids, and Asthma in African American Youth

NCT ID: NCT01647399

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

273 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phenotypic Clusters

500 urban youth

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert J. Freishtat

OTHER

Sponsor Role lead

Responsible Party

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Robert J. Freishtat

Attending Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert J Freishtat, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

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Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Maltz L, Matz EL, Gordish-Dressman H, Pillai DK, Teach SJ, Camargo CA Jr, Hubal MJ, Behniwal S, Prosper GD, Certner N, Marwah R, Mansell DM, Nwachukwu F, Lazaroff R, Tsegaye Y, Freishtat RJ. Sex differences in the association between neck circumference and asthma. Pediatr Pulmonol. 2016 Sep;51(9):893-900. doi: 10.1002/ppul.23381. Epub 2016 Jan 15.

Reference Type DERIVED
PMID: 26774073 (View on PubMed)

Related Links

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Other Identifiers

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R01MD007075-01

Identifier Type: NIH

Identifier Source: org_study_id

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