Antioxidant Therapy for Cystic Fibrosis
(CF-AOX Trial)
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.12345
Is antioxidant therapy safe for humans?
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.12578
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Chronic Antioxidant Treatment
Participants receive daily antioxidant treatment and undergo assessments at baseline, 4 weeks, 8 weeks, and 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Acute Antioxidant
- Chronic Antioxidant
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Augusta University
Lead Sponsor