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Clinical trial

Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis

ID
Name
HM20016707
Description
The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.
Trial arms
Trial start
2020-02-17
Estimated PCD
2025-01-01
Trial end
2025-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Resveratrol
500 mg resveratrol, BID
Arms:
A: Cystic fibrosis, A: Healthy Controls
NR
500 mg NR BID
Arms:
B: Cystic Fibrosis, B: Healthy Controls
Placebo
Placebo
Arms:
A: Cystic fibrosis, A: Healthy Controls, B: Cystic Fibrosis, B: Healthy Controls
Size
36
Primary endpoint
Change in Sirtuin1 (Sirt1)
Change from baseline to up to 20 weeks
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}
Updated at
2024-04-26

1 organization

2 products

1 indication

Organization
Virginia Commonwealth University
Product
Resveratrol
Indication
Cystic Fibrosis
Product
NR