Non-pulmonary Contributors of Exercise Intolerance in Pat... | NCT04166396

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

NCT04166396

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Jul 3, 2025Actual

Enrollment

8Actual

Phase

Early Phase 1

Conditions

Cystic Fibrosis

Interventions

Resveratrol
NR
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2020Actual

Primary Completion Date

Jul 30, 2024Actual

Completion Date

Jul 30, 2024Actual

First Submitted Date

Nov 14, 2019

First Submission Date that Met QC Criteria

Nov 14, 2019

First Posted Date

Nov 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2025

Last Update Posted Date

Jul 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A: Cystic fibrosis	Experimental	Patients with CF will be randomly assigned to resveratrol or placebo.	Drug: Resveratrol Dietary Supplement: Placebo
A: Healthy Controls	Experimental	Healthy controls will be randomly assigned to resveratrol or placebo	Drug: Resveratrol Dietary Supplement: Placebo
B: Cystic Fibrosis	Experimental	Patients with CF will be randomly assigned to NR or placebo.	Drug: NR Dietary Supplement: Placebo
B: Healthy Controls	Experimental	Healthy controls will be randomly assigned to NR or placebo	Drug: NR Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resveratrol	Drug	500 mg resveratrol, BID	A: Cystic fibrosis A: Healthy Controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Sirtuin1 (Sirt1)	Sirt1 will be assessed via a standard assay from samples taken from the participant's vein	Change from baseline to up to 20 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paula Rodriguez Miguelez, PhD	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077185	Resveratrol

Ancestor Terms

ID	Term
D000081225	Stilbestrols
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided