CoQ10 for Fatigue in Crohn's Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

This trial is for adults aged 18-70 with Crohn's disease who have been stable on their medication for at least a month and are not currently experiencing severe symptoms. Participants must be able to take oral meds and complete electronic surveys. There's also a group of healthy volunteers taking CoQ10.

Inclusion Criteria

I can take pills by mouth.

Prescreening PROMIS Fatigue 7a T score <55 (Cohort 2 and Cohort 3)

I have been on a stable Crohn's disease medication for at least 4 weeks.

Exclusion Criteria

I have been diagnosed with or reported having chronic fatigue syndrome.

B12 deficiency - <180 pg/mL on the screening laboratory tests

I have sleep apnea that has not been treated.

Participant Groups

The study tests two different doses of CoQ10 over an 8-week period in Crohn's patients, aiming to reduce fatigue as measured by the PROMIS Fatigue instrument and improve quality of life via the sIBDQ questionnaire. Healthy controls will take CoQ10 for two weeks.

Group I: Cohort 3 Healthy Volunteers Experimental Treatment 1 Intervention

Group II: Cohort 1 Crohn's Disease Patients with Fatigue Experimental Treatment 1 Intervention

Group III: Cohort 2 Crohn's Disease without Fatigue Active Control 1 Intervention

CoQ10 is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as CoQ10 for:

• Dietary supplement for mitochondrial support

🇪🇺 Approved in European Union as CoQ10 for:

• Dietary supplement for energy metabolism support

🇨🇦 Approved in Canada as CoQ10 for:

• Natural health product for antioxidant support

🇯🇵 Approved in Japan as CoQ10 for:

• Food for specified health uses for heart health support

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania Lead Sponsor

References