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

NCT ID: NCT06419335

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2026-06-01

Brief 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).

Conditions

Crohn Disease; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort 1 Crohn's Disease Patients with Fatigue

Group Type: EXPERIMENTAL

CoQ10

Intervention Type: DRUG

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).

Cohort 2 Crohn's Disease without Fatigue

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cohort 3 Healthy Volunteers

Group Type: EXPERIMENTAL

CoQ10

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

1. Prescreening PROMIS Fatigue 7a T score <55

Exclusion Criteria

1. Pregnant or lactating - a blood pregnancy test will be administered - fatigue is common with pregnancy and the post-partum period and is more likely to be unrelated to Crohn's

2. Chronic fatigue syndrome - noted in the medical record or self-reported

3. Depression as measured with PROMIS Depression scale 7a with T score >=60

4. New York Heart Association (NYHA) class 3 or greater heart failure - if noted in the medical record

5. Untreated sleep apnea

6. Abnormal Thyroid Stimulating Hormone (TSH) - <0.45 μlU/mL or >5.33 μlU/mL

7. Iron deficiency or anemia - ferritin < 20 without anemia or <100 with anemia (hemoglobin < 12g/dL in females or 13.5 g/dL in males) on the screening laboratory tests

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

9. Stage 3B or higher Chronic Kidney Disease (CKD) - based on an estimated glomerular filtration rate (eGFR) < 45 ml/min on the screening laboratory tests

10. Diagnosis of cirrhosis - if noted in the medical record or self-reported

11. Diagnosis of primary sclerosing cholangitis

12. Diagnosis with hepatitis C without evidence of successful eradication

13. Cancer and receiving chemotherapy - if noted in the medical record or self-reported

14. Multiple Sclerosis - self-reported on in chart.

15. Taking systemic corticosteroids (e.g. prednisone or budesonide), not including single doses given to prevent adverse reactions to a medication or contrast agent

16. Taking warfarin - if noted in the medical record or self-reported

17. Diabetes requiring medication - if noted in the medical record or self-reported

18. Symptoms of an infection in the last 2 weeks - self-reported

19. Any other comorbidity or condition that the PI thinks is a contraindication to participation in this study

1. Previous intolerance to CoQ10

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

855592

Identifier Type: -

Identifier Source: org_study_id