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Antioxidant Therapy for Cystic Fibrosis (CF-AOX Trial)

N/A

Waitlist Available

Led By Ryan Harris, Ph.D.

Research Sponsored by Augusta University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CF and healthy controls

Traditional CF-treatment medications

Must not have

Children 6 yrs. old and younger

Clinical diagnosis of heart disease, PAH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, week 8, and week 12

Summary

This trial will explore if oxidative stress contributes to both artery dysfunction and exercise intolerance in CF patients.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed here, antioxidant supplements may sometimes cause digestive discomfort or allergic reactions. Placebos typically do not cause side effects but participants' underlying conditions could influence their experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cystic fibrosis.

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I am on standard treatments for cystic fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child is 6 years old or younger.

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I have been diagnosed with heart disease or pulmonary arterial hypertension.

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I am taking medication for blood pressure or heart conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, week 8, and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, week 8, and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Change in Flow mediated dilation

Acute Change in exercise capacity (VO2 peak)

Chronic Change in Flow mediated dilation

+1 more

Trial Design

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.

0 / 5Eligibility criteria met