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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04166396
• Other study ID #: HM20016707
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 17, 2020
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: Paula Rodriguez Miguelez, PhD
• Phone: 804-828-8088
• Email: prodriguezmig[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.

Description:

Exercise intolerance is a critical problem for people with cystic fibrosis (CF) able to predict hospitalization independent of lung function. Recent studies have suggested that certain supplements may help improving exercise intolerance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Resveratrol
500 mg resveratrol, BID
• NR
500 mg NR BID

Dietary Supplement:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sirtuin1 (Sirt1)	Sirt1 will be assessed via a standard assay from samples taken from the participant's vein	Change from baseline to up to 20 weeks