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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2024-07-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A: Cystic fibrosis

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

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

500 mg resveratrol, BID

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

A: Healthy Controls

Healthy controls will be randomly assigned to resveratrol or placebo

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

500 mg resveratrol, BID

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

B: Cystic Fibrosis

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

Group Type EXPERIMENTAL

NR

Intervention Type DRUG

500 mg NR BID

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

B: Healthy Controls

Healthy controls will be randomly assigned to NR or placebo

Group Type EXPERIMENTAL

NR

Intervention Type DRUG

500 mg NR BID

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Resveratrol

500 mg resveratrol, BID

Intervention Type DRUG

NR

500 mg NR BID

Intervention Type DRUG

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes