NCT04166396CompletedEarly phase 1
Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 14 Nov 2019
- Start date
- 17 Feb 2020
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Cystic fibrosis
- NCT number
- NCT04166396
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 8
- From 17 Feb 2020 to the primary completion date, 30 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)
Other illness
- Clinical diagnosis of heart disease
- Febrile illness within 4 weeks of a study visit
Age
- Children 17 years old and younger
Other
- CF
- FEV1\<40% predicted
- Resting O2 saturation \<90%
- Clinical diagnosis of PAH
- Antioxidant for pulmonary exacerbation within 4 weeks of a study visit
- Currently smoking, pregnant or nursing
- Patients with B. Cepacia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.