What side effects are associated with this type of intervention?

Common treatments for cystic fibrosis include antibiotics, mucolytics, anti-inflammatory agents, and pancreatic enzyme supplements. Antibiotics can cause gastrointestinal upset, allergic reactions, and antibiotic resistance. Mucolytics like dornase alfa may lead to voice alteration and throat irritation. Anti-inflammatory agents such as ibuprofen can cause gastrointestinal bleeding and renal impairment. Pancreatic enzyme supplements may result in gastrointestinal discomfort and fibrosing colonopathy. Antioxidant supplements, which are being studied for their potential to reduce oxidative stress, have uncertain benefits and their side effects are not well-documented, but they may include gastrointestinal issues and potential interactions with other medications.

What prior FDA approvals exist?

The FDA has approved several treatments for cystic fibrosis, focusing on various aspects of the disease. One notable approval is for inhaled mannitol, which received regulatory approval in the US in 2020 for adults with CF. This treatment helps with airway clearance but is not specifically an antioxidant. While the context mentions studies on antioxidant supplements like N-acetylcysteine (NAC) and vitamin E for their potential benefits in CF, these have not been highlighted as FDA-approved treatments specifically for reducing oxidative stress in CF patients. The novel micellar formulation (CF-1) being studied aims to improve plasma levels of fat-soluble nutrients and antioxidants, but it is still under investigation and not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to antioxidant supplements for reducing oxidative stress in cystic fibrosis patients include: 1) CFTR modulators such as elexacaftor/tezacaftor/ivacaftor, which improve the function of the defective CFTR protein, 2) Gene therapy approaches aiming to correct the underlying genetic defect, and 3) Anti-inflammatory agents that target specific pathways involved in the inflammatory response in CF. These alternatives have shown potential in improving clinical outcomes and reducing oxidative stress in CF patients.

← Back to Search

Antioxidant Supplement

Antioxidant Supplements for Cystic Fibrosis

Q: What is the mechanism of action of this treatment?

Common treatments for Cystic Fibrosis (CF) include CFTR modulators, antibiotics, mucolytics, and antioxidant supplements. CFTR modulators, such as ivacaftor and lumacaftor, work by improving the function of the defective CFTR protein, which is crucial for maintaining proper ion balance and hydration of mucus. Antibiotics are used to manage chronic respiratory infections by reducing bacterial load and inflammation. Mucolytics, like N-acetylcysteine, help liquefy thick mucus, facilitating its clearance from the lungs. Antioxidant supplements aim to reduce oxidative stress, which is elevated in CF due to chronic inflammation and infection, thereby potentially improving lung function and overall health. These treatments are vital for CF patients as they address the underlying genetic defect, manage infections, and improve mucus clearance, ultimately enhancing quality of life and survival.

Phase < 1

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

Must not have

Clinical diagnosis of heart disease

Clinical diagnosis of PAH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to up to 20 weeks

Summary

This trial is testing if antioxidant supplements can help people with cystic fibrosis (CF) exercise better. People with CF often struggle with exercise, which can lead to more hospital visits. Antioxidants might help by protecting their cells from damage, making it easier for them to stay active. Glutathione, an antioxidant, has shown potential in improving lung function and reducing oxidative stress in cystic fibrosis patients.

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.

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.

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 below

Select...

I have been diagnosed with cystic fibrosis.

Select...

I am taking traditional CF antioxidant medications.

Exclusion Criteria

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

Select...

I have been diagnosed with heart disease.

Select...

I have been diagnosed with pulmonary arterial hypertension.

Select...

I am taking medication for blood pressure or heart issues.

Select...

I am 17 years old or younger.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to up to 20 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cystic Fibrosis (CF) include CFTR modulators, antibiotics, mucolytics, and antioxidant supplements. CFTR modulators, such as ivacaftor and lumacaftor, work by improving the function of the defective CFTR protein, which is crucial for maintaining proper ion balance and hydration of mucus. Antibiotics are used to manage chronic respiratory infections by reducing bacterial load and inflammation. Mucolytics, like N-acetylcysteine, help liquefy thick mucus, facilitating its clearance from the lungs. Antioxidant supplements aim to reduce oxidative stress, which is elevated in CF due to chronic inflammation and infection, thereby potentially improving lung function and overall health. These treatments are vital for CF patients as they address the underlying genetic defect, manage infections, and improve mucus clearance, ultimately enhancing quality of life and survival.

Cystic fibrosis transmembrane conductance regulator (CFTR) and autophagy: hereditary defects in cystic fibrosis versus gluten-mediated inhibition in celiac disease.Cystic fibrosis: a clinical view.Treatment options for cystic fibrosis: state of the art and future perspectives.