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Antioxidant Supplement
Antioxidant Supplements for Cystic Fibrosis
N/A
Recruiting
Led By Paula Rodriguez Miguelez, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CF
Traditional CF-antioxidant medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to up to 20 weeks
Awards & highlights
Study Summary
This trial will see if taking antioxidant supplements can help improve exercise ability in people with CF.
Who is the study for?
This trial is for adults over 18 with Cystic Fibrosis who can perform lung function tests and have an FEV1 percent predicted above 40%. They must not be current smokers, pregnant, or nursing, and should be clinically stable without recent exacerbations or heart disease.Check my eligibility
What is being tested?
The study is testing the effects of antioxidant supplements Resveratrol and NR on exercise intolerance in CF patients compared to a placebo. Participants will receive one of these treatments to see if it improves their ability to exercise.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea due to Resveratrol or NR. Since they are antioxidants, there's also a chance of allergic reactions or interactions with other medications.
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 taking traditional CF antioxidant medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to up to 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to up to 20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Sirtuin1 (Sirt1)
Trial Design
4Treatment groups
Experimental Treatment
Group I: B: Healthy ControlsExperimental Treatment2 Interventions
Healthy controls will be randomly assigned to NR or placebo
Group II: B: Cystic FibrosisExperimental Treatment2 Interventions
Patients with CF will be randomly assigned to NR or placebo.
Group III: A: Healthy ControlsExperimental Treatment2 Interventions
Healthy controls will be randomly assigned to resveratrol or placebo
Group IV: A: Cystic fibrosisExperimental Treatment2 Interventions
Patients with CF will be randomly assigned to resveratrol or placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resveratrol
2014
Completed Phase 3
~730
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
698 Previous Clinical Trials
22,884,959 Total Patients Enrolled
5 Trials studying Cystic Fibrosis
114 Patients Enrolled for Cystic Fibrosis
Paula Rodriguez Miguelez, PhDPrincipal InvestigatorVirginia Commonwealth University
2 Previous Clinical Trials
83 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been medically stable for the last 4 weeks.You may or may not have diabetes related to cystic fibrosis.I have not had a fever or flu-like illness in the last 4 weeks.I have been diagnosed with cystic fibrosis.I am over 18 years old.I have been diagnosed with heart disease.You can reliably do breathing tests.Patients with B. Cepacia infection.Your lung function is less than 40% of what is expected for someone your age and size.I have been diagnosed with pulmonary arterial hypertension.I am taking traditional CF antioxidant medications.Your oxygen level at rest is less than 90%.My pancreas works partially or not at all.Your lung function is better than 40% of what is expected for someone your age and size.I am taking medication for blood pressure or heart issues.I am 17 years old or younger.Your oxygen levels while resting are higher than 90%.I haven't taken antioxidants for lung issues in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: B: Healthy Controls
- Group 2: A: Cystic fibrosis
- Group 3: B: Cystic Fibrosis
- Group 4: A: Healthy Controls
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.
To what extent is the sample size of this research endeavor?
"Absolutely. Clinicaltrials.gov contains evidence that this trial is actively recruiting, and it was originally posted on February 17th 2020 before being updated most recently in July 19th 2022. The researchers are searching for 36 participants to be enrolled at one medical centre."
Answered by AI
Is this experiment still open to participants?
"Clinicaltrials.gov confirms that this medical experiment is currently recruiting participants, with the initial announcement posted on February 17th 2020 and last updated on July 19th 2022."
Answered by AI
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