AsthmaNCT00628329
Vitamin A, Its Receptors and Asthma
An observational study of Asthma, run by University of Kansas at 1 site in United States.
Trial summary
We wish to understand the association of Vitamin A serum levels and Vitamin A receptor number and responsiveness in asthmatics. We believe that Vitamin A receptors may be less prevalent in asthmatics and their responsiveness decreased. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2012
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male or female Age 18-64
Who may be able to join
- Patients with previously diagnosed asthma on inhaled corticosteroids, systemic steroids and/or long acting beta agonist (for a period of 6 mo to 5 years)
- Age 18-64
- Male or female
Who cannot join
- Children under age 18
- Adults 65 or older
- Patients with COPD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Vitamin A, Its Receptors and Asthma: Vitamin A Levels in Serum and Expression and Responsiveness of Vitamin A Receptors in Circulating Mononuclear Cells of Asthmatics
We wish to understand the association of Vitamin A serum levels and Vitamin A receptor number and responsiveness in asthmatics. We believe that Vitamin A receptors may be less prevalent in asthmatics and their responsiveness decreased.
Read the detailed description
We wish to define the association of asthma, vitamin A serum levels and vitamin A receptor number and responsiveness on circulating mononuclear cells. Asthma is a complex, heterogenous and often debilitating and potentially deadly disease. The causes for asthma are many, with susceptibility and resistance to treatment is poorly understood. Ultimately, looking at this disease from another angle such as the role of Vitamin A and/or receptors can help us learn more about the pathophysiology and treatment of asthma.
- Conditions
- Asthma
- Keywords
- asthma, retinol, cis-retinoic acid
- Medical subject headings
- Asthma
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 |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinol levels in blood, flow cytometric study of the RXRRAR receptors before and after addition of ATRA, 9-cis-RA and steroid
Measured: 2-4 weeks after blood sample drawn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selina Gierer, D.O., University of Kansas
- Investigators
- Daniel Stechschulte, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628329
- Sponsor's protocol ID
- 11213
- Status last verified
- May 2012
- First submitted
- 26 Feb 2008
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A, Its Receptors and Asthma: Vitamin A Levels in Serum and Expression and Responsiveness of Vitamin A Receptors in Circulating Mononuclear Cells of Asthmatics
- ClinicalTrials.gov ID
- NCT00628329
- Acronym / sponsor ID
- 11213
- Conditions
- Asthma
- Keywords
- asthma, retinol, cis-retinoic acid
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Mar 2008 (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.
We wish to understand the association of Vitamin A serum levels and Vitamin A receptor number and responsiveness in asthmatics. We believe that Vitamin A receptors may be less prevalent in asthmatics and their responsiveness decreased.
Detailed description
We wish to define the association of asthma, vitamin A serum levels and vitamin A receptor number and responsiveness on circulating mononuclear cells. Asthma is a complex, heterogenous and often debilitating and potentially deadly disease. The causes for asthma are many, with susceptibility and resistance to treatment is poorly understood. Ultimately, looking at this disease from another angle such as the role of Vitamin A and/or receptors can help us learn more about the pathophysiology and treatment of asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male or female Age 18-64
Key inclusion criteria (3 listed)
- Patients with previously diagnosed asthma on inhaled corticosteroids, systemic steroids and/or long acting beta agonist (for a period of 6 mo to 5 years)
- Age 18-64
- Male or female
Key exclusion criteria (3 listed)
- Children under age 18
- Adults 65 or older
- Patients with COPD
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
Retinol levels in blood, flow cytometric study of the RXRRAR receptors before and after addition of ATRA, 9-cis-RA and steroid
Time frame: 2-4 weeks after blood sample drawn
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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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.
Daniel Stechschulte, MD principal investigator
University of Kansas Medical Center
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, run by University of Kansas 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 3 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: withdrawn, as of the sponsor's last update on 7 May 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
Retinol levels in blood, flow cytometric study of the RXRRAR receptors before and after addition of ATRA, 9-cis-RA and steroid (time frame: 2-4 weeks after blood sample drawn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2012.