Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF (CF-AOX)
Cystic Fibrosis
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Endothelial Function, Maximal Exercise Capacity, Flow Mediated Dilation, Antioxidant, FEV1
Eligibility Criteria
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
Sites / Locations
- Georgia Prevention Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Acute Antioxidant Treatment
Chronic Antioxidant Treatment
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.
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.