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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Children's Research Institute
Sponsor:
Information provided by (Responsible Party):
Robert J. Freishtat, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01647399
First received: July 19, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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
Asthma
Allergy

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:

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)
Groups/Cohorts
Phenotypic Clusters
500 urban youth

  Eligibility

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.

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
  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 ClinicalTrials.gov identifier: NCT01647399

Contacts
Contact: Robert J Freishtat, MD, MPH 202-476-5000 ext 2971 rfreishtat@childrensnational.org

Locations
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    rfreishtat@cnmcresearch.org   
Principal Investigator: Robert J Freishtat, MD, MPH         
Sponsors and Collaborators
Children's Research Institute
Investigators
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
ClinicalTrials.gov Identifier: NCT01647399     History of Changes
Other Study ID Numbers: R01MD007075-01
Study First Received: July 19, 2012
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
Obesity
Asthma
Vitamin D
Allergy
Genetic
Childhood
Pediatric
cohort
observational
prospective
molecular

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

ClinicalTrials.gov processed this record on August 20, 2014