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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, and week 12
Awards & highlights
CF-AOX Trial 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.Check my eligibility
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.See study design
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.
CF-AOX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with cystic fibrosis.
Select...
I am on standard treatments for cystic fibrosis.
CF-AOX Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Change in Flow mediated dilation
Acute Change in exercise capacity (VO2 peak)
Chronic Change in Flow mediated dilation
+1 moreCF-AOX 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.
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
85,055 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
143 Patients Enrolled for Cystic Fibrosis
Ryan Harris, Ph.D.4.7122 ReviewsPrincipal Investigator - Augusta University
Medical School - University of Kansas, Kansas City, Doctor of Medicine
Augusta University, Medical College of Georgia, Residency in Otolaryngology and Head and Neck Surgery
2 Previous Clinical Trials
339 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
19 Patients Enrolled for Cystic Fibrosis
5Patient Review
He's great and very straightforward.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is 6 years old or younger.Your lung function is very low, less than 30% of what's expected.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.You had a fever in the two weeks before the visit.You have a specific type of bacteria called B. cepacia.Your lung function, measured as FEV1 percent predicted, is greater than 30%.People with or without diabetes related to cystic fibrosis.I have been treated for a lung flare-up within the last 4 weeks.My pancreas works either partially or not at all.Your oxygen level when you are resting in normal air should be more than 90%.I am on standard treatments for cystic fibrosis.I have been diagnosed with heart disease or pulmonary arterial hypertension.I am taking medication for blood pressure or heart conditions.I am between 7 and 17 years old.You can reliably and consistently perform pulmonary function tests.Your oxygen levels while resting without extra oxygen are less than 90%.
Research Study Groups:
This trial has the following groups:- Group 1: Acute Antioxidant Treatment
- Group 2: Chronic Antioxidant Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this experiment still open?
"Per information from clinicaltrials.gov, this trial has stopped recruiting patients; the study was initially posted on April 1st 2015 and last modified on July 18th 2022. Alternatively, there are 125 other trials currently seeking participants for their research studies."
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