drugset / Trial / NCT06419335

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

NCT06419335

Phase 0 Active not recruiting 60 enrolled University of Pennsylvania
Non-randomizedParallel-groupOpen-labelOther

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).

Timeline

Start
2024-07-20
Primary completion
2026-04-30
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Coenzyme Q10 Other / unclassified

Indications