Antioxidant Therapy for Cystic Fibrosis
(CF-AOX Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRyan Harris, Ph.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Augusta University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ryan Harris, Ph.D.

Principal Investigator

Augusta University

Eligibility Criteria

This trial is for men, women, and children over 7 with cystic fibrosis who can perform lung function tests and have an FEV1 percent predicted over 30%. They must not be currently smoking or pregnant, haven't had a feverish illness recently, no heart disease diagnosis, and not on certain heart medications.

Inclusion Criteria

I have been medically stable without needing antibiotics for the past 2 weeks.

I have been diagnosed with cystic fibrosis.

I am over 18 years old.

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Exclusion Criteria

My child is 6 years old or younger.

Your lung function is very low, less than 30% of what's expected.

You had a fever in the two weeks before the visit.

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Treatment Details

Interventions

Acute Antioxidant (Antioxidant)
Chronic Antioxidant (Antioxidant)
Placebo (Other)

Trial OverviewThe study examines the effects of oxidative stress on blood vessel function and exercise capacity in CF patients. Participants will receive either acute antioxidants, chronic antioxidants or a placebo to determine if these treatments improve their condition.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Chronic Antioxidant TreatmentExperimental Treatment1 Intervention

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.

Group II: Acute Antioxidant TreatmentExperimental Treatment2 Interventions

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.