Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study
Launched by UNIVERSITY OF PENNSYLVANIA · May 13, 2024
Trial Information
Current as of August 19, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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 \<55
- • Exclusion Criteria - for all study participants
- • 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
- • Exclusion Criteria for Cohorts 1 and 3
- • 1. Previous intolerance to CoQ10
About University Of Pennsylvania
The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported