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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Children's Research Institute
Information provided by (Responsible Party):
Robert J. Freishtat, Children's Research Institute Identifier:
First received: July 19, 2012
Last updated: July 13, 2015
Last verified: July 2015

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AsthMaP 2: Vitamin D, Steroids, and Asthma in African American Youth

Resource links provided by NLM:

Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Serum 25(OH)D measurement by liquid chromatography-tandem mass spectrometry [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood, urine, tissue

Estimated Enrollment: 500
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Phenotypic Clusters
500 urban youth


Ages Eligible for Study:   6 Years to 20 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01647399

Contact: Robert J Freishtat, MD, MPH 202-476-5000 ext 2971

United States, District of Columbia
Children's National Medical Center Recruiting
Washington DC, District of Columbia, United States, 20010
Contact: Robert J Freishtat, MD, MPH    202-476-5000 ext 6011   
Principal Investigator: Robert J Freishtat, MD, MPH         
Sponsors and Collaborators
Robert J. Freishtat
Principal Investigator: Robert J Freishtat, MD, MPH Children's Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Robert J. Freishtat, Attending Physician, Children's Research Institute Identifier: NCT01647399     History of Changes
Other Study ID Numbers: R01MD007075-01
Study First Received: July 19, 2012
Last Updated: July 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
Vitamin D

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Vitamin D
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins processed this record on November 27, 2015