Examining the effects of antioxidant supplements on exercise intolerance in cystic fibrosis patients
Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis
This study is testing if taking antioxidant supplements can help people with cystic fibrosis exercise better and feel less tired.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT04166396 on ClinicalTrials.gov |
What this trial studies
This research investigates whether antioxidant supplements, specifically resveratrol and nicotinamide riboside, can improve exercise intolerance in individuals with cystic fibrosis (CF). Exercise intolerance is a significant issue for CF patients, often predicting hospitalization regardless of lung function. The study will involve administering these supplements to eligible participants and assessing their impact on exercise capacity. Participants must be clinically stable and meet specific criteria related to their CF condition.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a confirmed diagnosis of cystic fibrosis and an FEV1 percent predicted greater than 40%.
Not a fit: Patients with severe lung impairment (FEV1 less than 40%), those with heart disease, or individuals under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise tolerance and overall quality of life for patients with cystic fibrosis.
How similar studies have performed: While the approach of using antioxidant supplements for exercise intolerance in CF is relatively novel, previous studies have shown promising results with similar interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: CF * Diagnosis of CF * Men and women (\> 18 yrs. old) * FEV1 percent predicted \> 40% * Patients with or without CF related diabetes * Resting oxygen saturation (room air) \>90% * Traditional CF-antioxidant medications * Ability to perform reliable/reproducible PFTs * Clinically stable for 4 weeks (no exacerbations or need for antibiotic antioxidant within 4 weeks of testing or major change in medical status) * Pancreatic sufficient and pancreatic insufficient patients Exclusion Criteria: CF * Children 17 years old and younger * FEV1\<40% predicted * Resting O2 saturation \<90% * Clinical diagnosis of heart disease * Clinical diagnosis of PAH * Febrile illness within 4 weeks of a study visit * Antioxidant for pulmonary exacerbation within 4 weeks of a study visit * Currently smoking, pregnant or nursing * Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.) * Patients with B. Cepacia
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Paula Rodriguez Miguelez, PhD — Virginia Commonwealth University
- Study coordinator: Paula Rodriguez Miguelez, PhD
- Email: prodriguezmig@vcu.edu
- Phone: 804-828-8088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.