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

Virginia Commonwealth University (VCU) logo

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

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

Trial contacts and locations

1

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Central trial contact

Paula Rodriguez Miguelez, PhD

Data sourced from clinicaltrials.gov

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