Vitamin D, Steroids, and Asthma in African American Youth

NCT01647399 | Completed DMC

• 1 other identifier: R01MD007075-01
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Allergy

Keywords

Obesity; Asthma; Vitamin D; Allergy; Genetic; Childhood; Pediatric; cohort; observational; prospective; molecular

Outcome Measures

Primary Outcomes (1)

• Serum 25(OH)D measurement by liquid chromatography-tandem mass spectrometry

  one year

Study Arms (1)

Phenotypic Clusters

500 urban youth

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Significant, chronic medical illnesses other than asthma
• No access to a phone

Sponsors & Collaborators

• Robert J. Freishtat: lead

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Maltz L, Matz EL, Gordish-Dressman H, Pillai DK, Teach SJ, Camargo CA Jr, Hubal MJ, Behniwal S, Prosper GD, Certner N, Marwah R, Mansell DM, Nwachukwu F, Lazaroff R, Tsegaye Y, Freishtat RJ. Sex differences in the association between neck circumference and asthma. Pediatr Pulmonol. 2016 Sep;51(9):893-900. doi: 10.1002/ppul.23381. Epub 2016 Jan 15.

  PMID: 26774073 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, tissue

MeSH Terms

Conditions

Asthma; Hypersensitivity; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert J Freishtat, MD, MPH

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 23, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: July 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

US (1)