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ACTIVE NOT RECRUITING
NCT06419335
EARLY_PHASE1

Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

Summary

This study includes an open label clinical trial comparing two doses of CoQ10 for 8 weeks to improve fatigue among patients with Crohn's disease and a prospective cohort study of healthy controls taking CoQ10 for 2 weeks. Additionally, among 15 participants who do not meet the fatigue threshold for the open label trial, the investigators will measure CoQ10 levels in blood and fasting urine, as well as complete the same data collection. Hypotheses 1. Fatigue will improve with CoQ10 and there will be a dose response with greater improvement with higher dose as measured by the Patient Reported Outcomes Measurement Information Systems Fatigue PROMIS Fatigue 7a instrument. 2. Fatigue will improve when measured with other fatigue scales in a similar dose dependent manner and that general and physical fatigue will improve more than mental fatigue. 3. CoQ10 will improve quality of life as measured with the short Inflammatory Bowel Disease Questionnaire (sIBDQ).

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-07-20

Completion Date

2026-06-01

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

DRUG

CoQ10

The core component of this pilot study will be a single center open label randomized trial comparing low dose and high dose CoQ10 among 30 patients with Crohn's disease and fatigue (Cohort 1) and 15 healthy volunteers (Cohort 3).

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States