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Active Not Recruiting
NCT06419335
Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study
Conditions: Crohn Disease, Healthy
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 60
Sponsor: University of Pennsylvania
Location: University of Pennsylvania Philadelphia Pennsylvania
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).
Eligibility Criteria
Inclusion Criteria for all study participants
To be eligible for this study all study participants must meet the following:
1. Provide informed consent
2. Male or female, age 18-70
3. Ability to take an oral medication
4. Willingness and ability to do electronic surveys
Additional inclusion criteria for Cohort 1 and Cohort 2 participants:
1. Must have Crohn's disease for at least 3 months
2. Must be on stable medication regimen for Crohn's disease for at least 4 weeks
3. Clinically quiescent Crohn's disease based on the Patient Reported Outcome -Crohn's Disease (PRO2) average score for up to 7 days - daily liquid or very soft stool frequency of ≤1.5 and abdominal pain ≤1.0 5.3 Additional inclusion criteria for Cohort 1
1\. Prescreening PROMIS Fatigue 7a T score \>60 5.4 Additional inclusion criteria for Cohort 2 and 3
1\. Prescreening PROMIS Fatigue 7a T score \
Source: ClinicalTrials.gov (NCT06419335). StuddyBuddy aggregates publicly available trial information.