Exercise-induced BronchospasmNCT03610932
Vitamin C & Exercise Induced Bronchoconstriction (EIB)
A study testing Vitamin C in people with Exercise-induced Bronchospasm, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to assess the association between diet and pulmonary function during standardized EIB testing. Determine the effect of Vitamin C supplementation on airway inflammatory markers and bronchoconstriction after a standardized EIB test compared to usual diet and placebo control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise-induced Bronchospasm
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 3 May 2019
- Phase
- Interventional
- 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
Who may be able to join
- Student or student-athlete who has tested positive for EIB
- Able to communicate in English
Who cannot join
- Forced expiratory volume in 1 second (FEV1) < 70% of predicted, cardiac history,
- Current respiratory infection
- > 10 pack year history of smoking
- Pregnancy.
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 C Supplementation to Improve EIB in College Student-Athletes
The purpose of this research is to assess the association between diet and pulmonary function during standardized EIB testing. Determine the effect of Vitamin C supplementation on airway inflammatory markers and bronchoconstriction after a standardized EIB test compared to usual diet and placebo control.
Read the detailed description
This study will use a double-blind, randomized, cross-over design with subjects serving as their own controls. This study will be conducted over a consecutive five-week period.
All subjects will be asked to discontinue taking their short- and long-acting beta-agonist medication 12 and 24 hours respectively prior to data collection. Also, all subjects will be asked to refrain from caffeine, physical activity, and NSAID use 24 hours prior to testing. In addition all subjects will be asked to abstain from taking any vitamin supplement during the course of the study.
- Conditions
- Exercise-induced Bronchospasm
- Being tested
- Vitamin C, Placebo
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Taken as 3 500mg capsules.
PlaceboOther
Taken as 3 500mg capsules.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | Participants will ingest 3 (500 mg) capsules of Vitamin C each day for 2 weeks. Receives: Dietary Supplement: Vitamin C |
| Placebo | Active comparator | Participants will ingest a matched capsule for size and color to the Vitamin C supplement. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in airway inflammatory biomarkers
Urinary concentrations of cysteine leukotrienes (LTC4-LTE4), prostaglandin (9α,11β-PGF2), and creatinine will be measured.
Measured: Change from Baseline to End of Week 5
Secondary outcomes (4)
Change in quality of life: asthma quality of life questionnaire (AQLQ)
Asthma specific quality of life will be measured by the validated asthma quality of life questionnaire (AQLQ). The AQLQ includes 32 separate responses within 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). Each response option is based on a 7-point scale, where 1 represents maximal impairment and 7 indicates no impairment. Scores for the four domains and overall score are computed as averages of the item scores. The minimal important difference for overall and each domain, has been determined to be a change in score of 0.5 per item.
Measured: Change from Baseline to End of Week 5
Dietary Intake Questionnaire
Baseline dietary intake will be assessed by the National Cancer Institute's Diet Health Questionnaire II (DHQ II). It consists of 134 food items and 8 dietary supplement questions. It calculates the Healthy Eating Index (HEI) that is a measure of diet quality. Scores range from 0 to 100. The higher the score the healthier the diet.
Measured: Change from Baseline to End of Week 5
Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed during the EIB test by an integrated metabolic measurement system that will be used for measurement of oxygen consumption. The metabolic cart will be set to produce a 15-second average of the data collected during gas analyses for all tests.
Measured: Baseline
Pulmonary function testing
The outcome will measure the change in the first second of forced expiration (FEV1).
Measured: Change from Baseline to End of Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Jul 2018
- Primary completion3 May 2019
- Study completion3 May 2019
Why it stopped: Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced BronchospasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dave Burnett, PhD, RRT, AE-C, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610932
- Sponsor's protocol ID
- STUDY00140641
- Status last verified
- Dec 2019
- First submitted
- 7 Jun 2018
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C Supplementation to Improve EIB in College Student-Athletes
- ClinicalTrials.gov ID
- NCT03610932
- Acronym / sponsor ID
- STUDY00140641
- Conditions
- Exercise-induced Bronchospasm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 1 Aug 2018 (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 research is to assess the association between diet and pulmonary function during standardized EIB testing. Determine the effect of Vitamin C supplementation on airway inflammatory markers and bronchoconstriction after a standardized EIB test compared to usual diet and placebo control.
Detailed description
This study will use a double-blind, randomized, cross-over design with subjects serving as their own controls. This study will be conducted over a consecutive five-week period.
All subjects will be asked to discontinue taking their short- and long-acting beta-agonist medication 12 and 24 hours respectively prior to data collection. Also, all subjects will be asked to refrain from caffeine, physical activity, and NSAID use 24 hours prior to testing. In addition all subjects will be asked to abstain from taking any vitamin supplement during the course of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Dietary Supplement: Vitamin CParticipants will ingest 3 (500 mg) capsules of Vitamin C each day for 2 weeks. |
| Placebo | Active comparator | Other: PlaceboParticipants will ingest a matched capsule for size and color to the Vitamin C supplement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Student or student-athlete who has tested positive for EIB
- Able to communicate in English
Key exclusion criteria (4 listed)
- Forced expiratory volume in 1 second (FEV1) < 70% of predicted, cardiac history,
- Current respiratory infection
- > 10 pack year history of smoking
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CTaken as 3 500mg capsules. | Dietary supplement | Vitamin C |
| PlaceboTaken as 3 500mg capsules. | Other | Placebo |
Primary outcome
Change in airway inflammatory biomarkers
Time frame: Change from Baseline to End of Week 5
Urinary concentrations of cysteine leukotrienes (LTC4-LTE4), prostaglandin (9α,11β-PGF2), and creatinine will be measured.
4 secondary outcomes
Change in quality of life: asthma quality of life questionnaire (AQLQ)
Time frame: Change from Baseline to End of Week 5
Dietary Intake Questionnaire
Time frame: Change from Baseline to End of Week 5
Cardiorespiratory Fitness
Time frame: Baseline
Pulmonary function testing
Time frame: Change from Baseline to End of Week 5
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 13 Dec 2019.
Related trials for Exercise-induced Bronchospasm
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
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, RRT, AE-C 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?
A study testing Vitamin C in people with Exercise-induced Bronchospasm, 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 2 inclusion and 4 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 13 Dec 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 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?
Change in airway inflammatory biomarkers (time frame: Change from Baseline to End of Week 5). 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 13 Dec 2019.