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

Virginia Commonwealth University (VCU)

Status and phase: Enrolling; Early Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: NR; Dietary Supplement: Placebo; Drug: Resveratrol

Study type: Interventional

Funder types: Other

Identifiers

NCT04166396

HM20016707

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 4 patient groups

A: Cystic fibrosis

Experimental group

Description:

Patients with CF will be randomly assigned to resveratrol or placebo.

Treatment:

Dietary Supplement: Placebo

Drug: Resveratrol

A: Healthy Controls

Experimental group

Description:

Healthy controls will be randomly assigned to resveratrol or placebo

Treatment:

Dietary Supplement: Placebo

Drug: Resveratrol

B: Cystic Fibrosis

Experimental group

Description:

Patients with CF will be randomly assigned to NR or placebo.

Treatment:

Drug: NR

Dietary Supplement: Placebo

B: Healthy Controls

Experimental group

Description:

Healthy controls will be randomly assigned to NR or placebo

Treatment:

Drug: NR

Dietary Supplement: Placebo