Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 February 2024 |
Main ID: |
NCT02690064 |
Date of registration:
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19/02/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF
CF-AOX |
Scientific title:
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Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF |
Date of first enrolment:
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April 2015 |
Target sample size:
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13 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT02690064 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Ryan Harris, Ph.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Augusta University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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%
- 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
Exclusion Criteria:
- 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
- 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
Age minimum:
7 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Dietary Supplement: Chronic Antioxidant
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Other: Placebo
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Dietary Supplement: Acute Antioxidant
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Primary Outcome(s)
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Acute Change in exercise capacity (VO2 peak)
[Time Frame: Baseline and 2 hours following acute antioxidant treatment]
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Chronic Change in exercise capacity (VO2 peak)
[Time Frame: Baseline, week 4, week 8, and week 12]
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Chronic Change in Flow mediated dilation
[Time Frame: Baseline, week 4, week 8, and week 12]
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Acute Change in Flow mediated dilation
[Time Frame: Change from baseline (2 hours)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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