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Completed

NCT Number: NCT04166396

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

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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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Drug

500 mg resveratrol, BID

NR

Drug

500 mg NR BID

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Change in Sirtuin1 (Sirt1)

    Time frame: Change from baseline to up to 20 weeks

    Sirt1 will be assessed via a standard assay from samples taken from the participant's vein

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2019
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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