CoQ10 supplement trial aims to beat Crohn's fatigue
NCT ID NCT06419335
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether taking CoQ10 supplements for 8 weeks can ease fatigue in people with Crohn's disease. About 60 adults with stable Crohn's will receive one of two doses, and researchers will track changes in fatigue and quality of life. The goal is to see if a larger, more definitive study is worth doing.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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