AsthmaAsthMaP2NCT01647399
Vitamin D, Steroids, and Asthma in African American Youth
An observational study of Asthma and Allergy, run by Robert J. Freishtat at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Significant, chronic medical illnesses other than asthma
- No access to a phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: AsthMaP 2: Vitamin D, Steroids, and Asthma in African American Youth
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.
- Keywords
- Obesity, Asthma, Vitamin D, Allergy, Genetic, Childhood, Pediatric, cohort, observational, prospective, molecular
- Medical subject headings
- Asthma, Hypersensitivity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phenotypic Clusters | 500 urban youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D measurement by liquid chromatography-tandem mass spectrometry
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert J. Freishtat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert J. Freishtat, Children's National Research Institute
- Investigators
- Robert J Freishtat, MD, MPH, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647399
- Sponsor's protocol ID
- R01MD007075-01
- Acronym
- AsthMaP2
- Status last verified
- Mar 2019
- First submitted
- 19 Jul 2012
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26774073
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AsthMaP 2: Vitamin D, Steroids, and Asthma in African American Youth
- ClinicalTrials.gov ID
- NCT01647399
- Acronym / sponsor ID
- AsthMaP2 / R01MD007075-01
- Keywords
- Obesity, Asthma, Vitamin D, Allergy, Genetic, Childhood, Pediatric, cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Robert J. FreishtatUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phenotypic Clusters | – | –500 urban youth |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Significant, chronic medical illnesses other than asthma
- No access to a phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum 25(OH)D measurement by liquid chromatography-tandem mass spectrometry
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Derived from this study: PubMed 26774073Maltz 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.
- Related InfoLink provided by the sponsor.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Freishtat, MD, MPH principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergy, run by Robert J. Freishtat at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH)D measurement by liquid chromatography-tandem mass spectrometry (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.