AsthmaNCT06636396
Feasibility of Measuring Skin Carotenoid Level in an Asthma Clinic
An observational study of Asthma, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the use of a practical tool to objectively measure the fruit and vegetable intake in people with asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 7 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All people with asthma who are at least 18 years of age.
Who may be able to join
- Pulmonary patients 18 years of age and older
- Confirmed diagnosis of asthma by a physician and confirmed by a pulmonary physician
- English speaking
- Access to the internet
Who cannot join
- Acute upper or lower respiratory infection
- Systemic corticosteroids
- Recent or current confirmed diagnosis of Covid-19
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to assess the use of a practical tool to objectively measure the fruit and vegetable intake in people with asthma.
Read the detailed description
After consenting to join the study, all participants enter a single cohort, cross-sectional study to assess pulmonary function, asthma control, carotenoid level, and diet intake.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
forced expiratory volume in one second
Measured: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.
ACT
Asthma control test results in a score of 5-25, with a lower score indicating better asthma control.
Measured: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.
Skin Carotenoid Level
Skin carotenoid level, measured with a non-invasive tool and is an indicator of fruit and vegetable intake. Skin carotenoid levels are shown as a score of 0-800, with a higher score representing a higher level of carotenoids.
Measured: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.
Diet Intake
Nutrascreen diet questionnaire to assess nutritional intake. Specifically, quantity of fruits and vegetable intake will be assessed.
Measured: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start8 Nov 2021
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
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.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dave Burnett, University of Kansas Medical Center
- Investigators
- Dave Burnett, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636396
- Sponsor's protocol ID
- STUDY00147843
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Measuring Skin Carotenoid Level in an Asthma Clinic
- ClinicalTrials.gov ID
- NCT06636396
- Acronym / sponsor ID
- STUDY00147843
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 10 Oct 2024 (actual)
- 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.
The purpose of this study is to assess the use of a practical tool to objectively measure the fruit and vegetable intake in people with asthma.
Detailed description
After consenting to join the study, all participants enter a single cohort, cross-sectional study to assess pulmonary function, asthma control, carotenoid level, and diet intake.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All people with asthma who are at least 18 years of age.
Key inclusion criteria (4 listed)
- Pulmonary patients 18 years of age and older
- Confirmed diagnosis of asthma by a physician and confirmed by a pulmonary physician
- English speaking
- Access to the internet
Key exclusion criteria (3 listed)
- Acute upper or lower respiratory infection
- Systemic corticosteroids
- Recent or current confirmed diagnosis of Covid-19
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
FEV1
Time frame: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.
forced expiratory volume in one second
ACT
Time frame: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.
Asthma control test results in a score of 5-25, with a lower score indicating better asthma control.
Skin Carotenoid Level
Time frame: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.
Skin carotenoid level, measured with a non-invasive tool and is an indicator of fruit and vegetable intake. Skin carotenoid levels are shown as a score of 0-800, with a higher score representing a higher level of carotenoids.
Diet Intake
Time frame: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.
Nutrascreen diet questionnaire to assess nutritional intake. Specifically, quantity of fruits and vegetable intake will be assessed.
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 10 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Dave Burnett, PhD principal investigator
Associate Professor
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 Medical Center 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 4 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: finished, as of the sponsor's last update on 10 Oct 2024. 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?
FEV1 (time frame: measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.). The study lists 4 primary outcomes in all. 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 10 Oct 2024.