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NCT01647399 · ClinicalTrials.gov registry record

Vitamin D, Steroids, and Asthma in African American Youth

A clinical trial of Asthma and Allergy, sponsored by Robert J. Freishtat.

Completed
Registry status
273
Enrollment target
1
Study location

NCT01647399 is a study of Asthma and Allergy that has completed, run by Robert J. Freishtat. The registered enrollment target is 273 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01647399, a study of Asthma and Allergy, has completed, sponsored by Robert J. Freishtat.

COMPLETED
Registry status
273 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Study Locations (1)

District of Columbia

  • Children's National Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 273 participants
Start Date 2012-07
Est. Completion 2018-07

Sponsor

Robert J. Freishtat

1 total trials

What the Registry Record Tells You About NCT01647399

The ClinicalTrials.gov registry entry for NCT01647399 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 273 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (83% lower). The listed sponsor is Robert J. Freishtat, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 0 interventions.

NCT01647399 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT01647399 about?

NCT01647399 is a clinical study titled "Vitamin D, Steroids, and Asthma in African American Youth". 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 re...

What is the current status of trial NCT01647399?

This trial is currently completed. The enrollment target is 273 participants. The study started on 2012-07. Estimated completion is 2018-07.

What conditions does trial NCT01647399 study?

This clinical trial studies the following conditions: Asthma, Allergy.

Who is sponsoring clinical trial NCT01647399?

This trial is sponsored by Robert J. Freishtat, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01647399 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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