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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01647399
Recruitment Status : Active, not recruiting
First Posted : July 23, 2012
Last Update Posted : August 16, 2017
Information provided by (Responsible Party):
Robert J. Freishtat, Children's 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

Study Type : Observational
Estimated Enrollment : 500 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
Primary Completion Date : August 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

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.

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 identifier (NCT number): NCT01647399

United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20010
Sponsors and Collaborators
Robert J. Freishtat
Principal Investigator: Robert J Freishtat, MD, MPH Children's Research Institute

Additional Information:
Responsible Party: Robert J. Freishtat, Attending Physician, Children's Research Institute Identifier: NCT01647399     History of Changes
Other Study ID Numbers: R01MD007075-01 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017

Keywords provided by Robert J. Freishtat, Children's Research Institute:
Vitamin D

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents