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CoQ10 supplement trial aims to beat Crohn's fatigue

NCT ID NCT06419335

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.