Vitamin D, Steroids, and Asthma in African American Youth (AsthMaP2)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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: | No |
| Sampling Method: | Non-Probability Sample |
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| Contact: Robert J Freishtat, MD, MPH | 202-476-5000 ext 1971 | rfreishtat@cnmresearch.org |
| 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 | |
| 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: | November 14, 2012 |
| 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 Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013