Cystic FibrosisCF-AOXNCT02690064
Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF
A study testing Acute Antioxidant and Chronic Antioxidant in people with Cystic Fibrosis, run by Augusta University at 1 site in United States.
Trial summary
Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections. However, the physiological mechanisms for this reduced exercise capacity are unknown. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Acute Antioxidant and Chronic Antioxidant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of CF and healthy controls
- Men and women (> 18 yrs. old)
- Boys and girls (7-17 yrs. old)
- FEV1 percent predicted > 30%
- Patients with or without CF related diabetes
- Resting oxygen saturation (room air) >90%
Show all 10Show fewer
- Traditional CF-treatment medications
- Ability to perform reliable/reproducible PFTs
- Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status)
- Pancreatic sufficient and pancreatic insufficient patients
Who cannot join
- Children 6 yrs. old and younger
- FEV1 percent predicted < 30%
- Resting oxygen saturation (room air) < 90%
- Clinical diagnosis of heart disease, PAH
- Febrile illness within two weeks of visit
- Currently smoking, pregnant, or nursing
Show all 9Show fewer
- Individuals on vaso-active medications (i.e. nitrates, beta blockers, ACE inhibitors, etc.)
- Patients with B. cepacia (only ~3% of our CF center patient population)
- Treatment for pulmonary exacerbation within 4 weeks of a study visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Prevention Institute
Augusta, Georgia, 30912
About this study
Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections. However, the physiological mechanisms for this reduced exercise capacity are unknown. The investigators recently published the first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in CF. This study will look at how and if oxidative stress contributes to both artery dysfunction and exercise intolerance in CF.
Read the detailed description
Cystic Fibrosis (CF) is the most common fatal genetic disease in North America. The most disturbing aspect of CF is the associated premature death, most often due to respiratory complications. Clinical manifestations of CF include not only lung dysfunction, but many other systemic consequences as well. Systemic oxidative stress and exercise intolerance are established phenotypes in patients with CF. Additionally, for the first time the investigators have recently published the presence of systemic endothelial dysfunction in a cohort of young patients with CF who exhibited normal oxygen saturation and spirometric function.
Exercise intolerance, the limitation of the ability to perform exercise at the expected level, has been shown to predict mortality in patients with CF independent of lung function. Exercise capacity (VO2 peak), an objective measurement of exercise tolerance, drops approximately 5-8% per year in patients with CF. This excessive decay in exercise capacity not only leads to more pulmonary infections and deterioration of lung function, it represents a 5-8 fold decline compared to healthy sedentary adults. Preventing the excessive annual reduction in exercise capacity is essential to increasing the quality of life and longevity of patients with CF. However, a critical barrier to improving exercise capacity in CF is the investigators lack of knowledge regarding the different physiological mechanisms that contribute to exercise intolerance. It is important to emphasize that decreases in lung function (FEV1) do not always contribute to reductions in VO2 peak. Furthermore, less than 2% of patients who have an FEV1 greater than 50% predicted will have a significant drop in hemoglobin oxygen saturation (SpO2) during maximal exercise. These data suggest that mechanisms other than lung function induced hypoxemia may be contributing to exercise intolerance in patients with CF.
- Conditions
- Cystic Fibrosis
- Being tested
- Acute Antioxidant, Chronic Antioxidant, Placebo
- Keywords
- Endothelial Function, Maximal Exercise Capacity, Flow Mediated Dilation, Antioxidant, FEV1
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute AntioxidantDietary supplement
Also called Vitamin C, Vitamin E, Alpha Lipoic Acid, Resveratrol
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Chronic AntioxidantDietary supplement
Also called Vitamin C, Vitamin E, Alpha Lipoic Acid, Resveratrol
Flow-Mediated Dilation will be determined at baseline, week 4, week 8, and week 12.
PlaceboOther
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
| Study group | Role | What they receive |
|---|---|---|
| Acute Antioxidant Treatment | Experimental | Following an overnight fast, blood samples, flow-mediated dilation, lung function, and exercise capacity (VO2 peak) (post only) will be performed at baseline and 2 hours following either a single dose oral 1) antioxidant cocktail (1000 mg Vitamin C, 600 IU vitamin E, 600 mg Alpha Lipoic Acid) 2) Resveratrol (1500 mg) 3) Mitoquinol (10 mg) or placebo on two days separated by at least 72 hours. Receives: Dietary Supplement: Acute Antioxidant; Other: Placebo |
| Chronic Antioxidant Treatment | Experimental | Following the completion of Arm 1, blood samples, flow-mediated dilation, lung function, and exercise capacity (VO2 peak) will be performed, only in patients with CF, at baseline, 4 weeks, 8 weeks, and 12 weeks following one of the following: 1) an anti-oxidant cocktail (vitamin C 1000 mg, vitamin E 400 IU, and alpha lipoic acid 600 mg) taken once a day, 2) 1500 mg Resveratrol once a day or 3) 10 mg Mitoquinol once a day. Receives: Dietary Supplement: Chronic Antioxidant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Change in Flow mediated dilation
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Measured: Change from baseline (2 hours)
Chronic Change in Flow mediated dilation
Flow-Mediated Dilation will be determined at baseline, week 4, week 8 and week 12.
Measured: Baseline, week 4, week 8, and week 12
Acute Change in exercise capacity (VO2 peak)
Subjects will perform a baseline maximal exercise capacity test and on a separate visit perform a maximal exercise capacity test 2 hours following acute antioxidant treatment
Measured: Baseline and 2 hours following acute antioxidant treatment
Chronic Change in exercise capacity (VO2 peak)
Subjects will perform a maximal exercise capacity test at baseline, week 4, week 8, and week 12.
Measured: Baseline, week 4, week 8, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Harris, Augusta University
- Investigators
- Ryan Harris, Ph.D., Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690064
- Sponsor's protocol ID
- CF-AOX
- Acronym
- CF-AOX
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2016
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF
- ClinicalTrials.gov ID
- NCT02690064
- Acronym / sponsor ID
- CF-AOX / CF-AOX
- Conditions
- Cystic Fibrosis
- Keywords
- Endothelial Function, Maximal Exercise Capacity, Flow Mediated Dilation, Antioxidant, FEV1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Feb 2016 (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.
Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections. However, the physiological mechanisms for this reduced exercise capacity are unknown. The investigators recently published the first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in CF. This study will look at how and if oxidative stress contributes to both artery dysfunction and exercise intolerance in CF.
Detailed description
Cystic Fibrosis (CF) is the most common fatal genetic disease in North America. The most disturbing aspect of CF is the associated premature death, most often due to respiratory complications. Clinical manifestations of CF include not only lung dysfunction, but many other systemic consequences as well. Systemic oxidative stress and exercise intolerance are established phenotypes in patients with CF. Additionally, for the first time the investigators have recently published the presence of systemic endothelial dysfunction in a cohort of young patients with CF who exhibited normal oxygen saturation and spirometric function.
Exercise intolerance, the limitation of the ability to perform exercise at the expected level, has been shown to predict mortality in patients with CF independent of lung function. Exercise capacity (VO2 peak), an objective measurement of exercise tolerance, drops approximately 5-8% per year in patients with CF. This excessive decay in exercise capacity not only leads to more pulmonary infections and deterioration of lung function, it represents a 5-8 fold decline compared to healthy sedentary adults. Preventing the excessive annual reduction in exercise capacity is essential to increasing the quality of life and longevity of patients with CF. However, a critical barrier to improving exercise capacity in CF is the investigators lack of knowledge regarding the different physiological mechanisms that contribute to exercise intolerance. It is important to emphasize that decreases in lung function (FEV1) do not always contribute to reductions in VO2 peak. Furthermore, less than 2% of patients who have an FEV1 greater than 50% predicted will have a significant drop in hemoglobin oxygen saturation (SpO2) during maximal exercise. These data suggest that mechanisms other than lung function induced hypoxemia may be contributing to exercise intolerance in patients with CF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Antioxidant Treatment | Experimental | Dietary Supplement: Acute Antioxidant, Other: PlaceboFollowing an overnight fast, blood samples, flow-mediated dilation, lung function, and exercise capacity (VO2 peak) (post only) will be performed at baseline and 2 hours following either a single dose oral 1) antioxidant cocktail (1000 mg Vitamin C, 600 IU vitamin E, 600 mg Alpha Lipoic Acid) 2) Resveratrol (1500 mg) 3) Mitoquinol (10 mg) or placebo on two days separated by at least 72 hours. |
| Chronic Antioxidant Treatment | Experimental | Dietary Supplement: Chronic AntioxidantFollowing the completion of Arm 1, blood samples, flow-mediated dilation, lung function, and exercise capacity (VO2 peak) will be performed, only in patients with CF, at baseline, 4 weeks, 8 weeks, and 12 weeks following one of the following: 1) an anti-oxidant cocktail (vitamin C 1000 mg, vitamin E 400 IU, and alpha lipoic acid 600 mg) taken once a day, 2) 1500 mg Resveratrol once a day or 3) 10 mg Mitoquinol once a day. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of CF and healthy controls
- Men and women (> 18 yrs. old)
- Boys and girls (7-17 yrs. old)
- FEV1 percent predicted > 30%
- Patients with or without CF related diabetes
Key exclusion criteria (9 listed)
- Children 6 yrs. old and younger
- FEV1 percent predicted < 30%
- Resting oxygen saturation (room air) < 90%
- Clinical diagnosis of heart disease, PAH
- Febrile illness within two weeks of visit
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 |
|---|---|---|
| Acute AntioxidantAlso: Vitamin C, Vitamin E, Alpha Lipoic Acid, ResveratrolFlow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment | Dietary supplement | Acute Antioxidant Treatment |
| Chronic AntioxidantAlso: Vitamin C, Vitamin E, Alpha Lipoic Acid, ResveratrolFlow-Mediated Dilation will be determined at baseline, week 4, week 8, and week 12. | Dietary supplement | Chronic Antioxidant Treatment |
| PlaceboFlow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment | Other | Acute Antioxidant Treatment |
Primary outcome
Acute Change in Flow mediated dilation
Time frame: Change from baseline (2 hours)
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Chronic Change in Flow mediated dilation
Time frame: Baseline, week 4, week 8, and week 12
Flow-Mediated Dilation will be determined at baseline, week 4, week 8 and week 12.
Acute Change in exercise capacity (VO2 peak)
Time frame: Baseline and 2 hours following acute antioxidant treatment
Subjects will perform a baseline maximal exercise capacity test and on a separate visit perform a maximal exercise capacity test 2 hours following acute antioxidant treatment
Chronic Change in exercise capacity (VO2 peak)
Time frame: Baseline, week 4, week 8, and week 12
Subjects will perform a maximal exercise capacity test at baseline, week 4, week 8, and week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
Ryan Harris, Ph.D. principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Antioxidant and Chronic Antioxidant in people with Cystic Fibrosis, run by Augusta University 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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acute Change in Flow mediated dilation (time frame: Change from baseline (2 hours)). 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 28 Jan 2025.