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Number of Visits: 6

13 Participants Needed

Antioxidant Therapy for Cystic Fibrosis
(CF-AOX Trial)

Overseen ByJacob Looney, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Must be taking: Traditional CF-treatment

Must not be taking: Vaso-active

Disqualifiers: Heart disease, PAH, Smoking, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on vaso-active medications (like nitrates, beta blockers, or ACE inhibitors).

What data supports the effectiveness of antioxidant therapy for cystic fibrosis?

Research shows that patients with cystic fibrosis often have low levels of antioxidants like beta-carotene and vitamin E, which are important for reducing oxidative stress (damage caused by free radicals). Studies suggest that supplementing with these antioxidants can improve certain laboratory markers, although more research is needed to confirm significant clinical benefits.¹ ² ³ ⁴ ⁵

Is antioxidant therapy safe for humans?

Antioxidant therapy, including supplements like beta-carotene and selenium, has been studied in cystic fibrosis patients and generally appears safe, though more rigorous trials are needed to confirm its safety and effectiveness.¹ ² ³ ⁶ ⁷

How does antioxidant therapy differ from other treatments for cystic fibrosis?

Antioxidant therapy for cystic fibrosis is unique because it focuses on reducing oxidative stress, which is a significant issue in CF patients due to their impaired antioxidant systems. This therapy often involves supplements like docosahexaenoic acid (DHA) and beta-carotene, which aim to boost antioxidant levels and improve overall health, unlike standard treatments that primarily address symptoms like lung infections and digestive issues.¹ ² ⁵ ⁷ ⁸

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.

See 7 more

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.

See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Antioxidant Treatment

Participants receive a single dose of antioxidant treatment and undergo assessments for blood samples, flow-mediated dilation, lung function, and exercise capacity

1 day

2 visits (in-person)

Chronic Antioxidant Treatment

Participants receive daily antioxidant treatment and undergo assessments at baseline, 4 weeks, 8 weeks, and 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Acute Antioxidant
Chronic Antioxidant
Placebo

Trial Overview 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.

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Findings from Research

This study compiled respiratory adverse event (AE) rates from placebo subjects in inhaled therapy trials for cystic fibrosis, revealing short-term AE rates of 1.1 events per person-week in pediatric and 1.0 in adult subjects, and long-term rates of 1.7 events per person-month in pediatric and 2.2 in adult subjects.

The research identified that factors like forced expiratory volume (FEV1) and age in short-term studies, and FEV1 and gender in long-term studies, were statistically significant in predicting respiratory AE rates, although the models had low predictive power.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory adverse event profiles in cystic fibrosis placebo subjects in short- and long-term inhaled therapy trials.Sucharew, H., Goss, CH., Millard, SP., et al.[2007]