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Vitamin D, Steroids, and Asthma in African American Youth (AsthMaP2)

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ClinicalTrials.gov Identifier: NCT01647399
Recruitment Status : Completed
First Posted : July 23, 2012
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Robert J. Freishtat, Children's National Research Institute

Brief 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.


Condition or disease
Asthma Allergy

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Study Type : Observational
Actual Enrollment : 273 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AsthMaP 2: Vitamin D, Steroids, and Asthma in African American Youth
Study Start Date : July 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Phenotypic Clusters
500 urban youth



Primary Outcome Measures :
  1. Serum 25(OH)D measurement by liquid chromatography-tandem mass spectrometry [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
Blood, urine, tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
AshMaP 2 subjects will be enrolled from all the sites in the Children's National Medical Center city-wide pediatric and adolescent health systems sites, including primary care offices (community and hospital-based), specialty clinics, Emergency Departments, and inpatient units.
Criteria

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

Information from the National Library of Medicine

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): NCT01647399


Locations
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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Robert J. Freishtat
Investigators
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Principal Investigator: Robert J Freishtat, MD, MPH Children's National Research Institute
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert J. Freishtat, Attending Physician, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT01647399    
Other Study ID Numbers: R01MD007075-01 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Keywords provided by Robert J. Freishtat, Children's National Research Institute:
Obesity
Asthma
Vitamin D
Allergy
Genetic
Childhood
Pediatric
cohort
observational
prospective
molecular
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases