Crohn DiseaseEarly Phase 1NCT06419335
Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study
A Early Phase 1 study testing CoQ10 in people with Crohn Disease and Healthy, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Healthy
- What is being tested?
- CoQ10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2024to 30 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for this study all study participants must meet the following:
- Provide informed consent
- Male or female, age 18-70
- Ability to take an oral medication
- Willingness and ability to do electronic surveys
- Additional inclusion criteria for Cohort 1 and Cohort 2 participants:
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- Must have Crohn's disease for at least 3 months
- Must be on stable medication regimen for Crohn's disease for at least 4 weeks
- 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
Who cannot join
- 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
- Chronic fatigue syndrome - noted in the medical record or self-reported
- Depression as measured with PROMIS Depression scale 7a with T score >=60
- New York Heart Association (NYHA) class 3 or greater heart failure - if noted in the medical record
- Untreated sleep apnea
- Abnormal Thyroid Stimulating Hormone (TSH) - <0.45 μlU/mL or >5.33 μlU/mL
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- 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
- B12 deficiency - <180 pg/mL on the screening laboratory tests
- Stage 3B or higher Chronic Kidney Disease (CKD) - based on an estimated glomerular filtration rate (eGFR) < 45 ml/min on the screening laboratory tests
- Diagnosis of cirrhosis - if noted in the medical record or self-reported
- Diagnosis of primary sclerosing cholangitis
- Diagnosis with hepatitis C without evidence of successful eradication
- Cancer and receiving chemotherapy - if noted in the medical record or self-reported
- Multiple Sclerosis - self-reported on in chart.
- Taking systemic corticosteroids (e.g. prednisone or budesonide), not including single doses given to prevent adverse reactions to a medication or contrast agent
- Taking warfarin - if noted in the medical record or self-reported
- Diabetes requiring medication - if noted in the medical record or self-reported
- Symptoms of an infection in the last 2 weeks - self-reported
- Any other comorbidity or condition that the PI thinks is a contraindication to participation in this study
- 1. Previous intolerance to CoQ10
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
- 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.
- 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.
- CoQ10 will improve quality of life as measured with the short Inflammatory Bowel Disease Questionnaire (sIBDQ).
- Conditions
- Crohn Disease, Healthy
- Being tested
- CoQ10
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Crohn's Disease Patients with Fatigue | Experimental | Not described Receives: Drug: CoQ10 |
| Cohort 2 Crohn's Disease without Fatigue | No intervention | Not described |
| Cohort 3 Healthy Volunteers | Experimental | Not described Receives: Drug: CoQ10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess improved fatigue among patients with Crohn's Disease
The primary objective of this study is to assess whether there is sufficient evidence of a change (greater than 7 points) in fatigue among patients with Crohn's disease taking CoQ10 to warrant conduct of a larger, placebo-controlled clinical trial. The primary outcome will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a, a unidimensional scale that has been well validated and tested among the general population and patients with IBD and many other chronic disorders. The scale ranges from 33.7 to 75.8. Higher scores indicate more greater fatigue.
Measured: 8 weeks
Secondary outcomes (1)
Change in domain specific fatigue
Secondary outcome measures will include improvement in domain specific fatigue, overall fatigue assessed with a different unidimensional scale using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) for changes in Inflammatory Bowel Disease(IBD)-related quality of life. The scale ranges from 0 to 52. Higher scores indicate better quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start20 Jul 2024
- Primary completion30 Apr 2026
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419335
- Sponsor's protocol ID
- 855592
- Status last verified
- Oct 2026
- First submitted
- 7 May 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication of the results of this study are planned. All publications emanating from this study will meet the authorship standards of the International Committee of Medical Journal Editors (ICMJE) standards. No data or samples obtained via this study will be shared with public repositories and there is no requirement to do so under the current funding mechanism for this study. If data or samples are shared with other investigators, they will be deidentified and the principal investigator will ensure that proper regulatory requirements are met before sharing the data. No data or samples will be provided outside of the University of Pennsylvania without an executed Material Transfer Agreement between the University of Pennsylvania and the institution receiving the data and or/samples.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study
- ClinicalTrials.gov ID
- NCT06419335
- Acronym / sponsor ID
- 855592
- Conditions
- Crohn Disease, Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- CoQ10 will improve quality of life as measured with the short Inflammatory Bowel Disease Questionnaire (sIBDQ).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Crohn's Disease Patients with Fatigue | Experimental | Drug: CoQ10 |
| Cohort 2 Crohn's Disease without Fatigue | No intervention | – |
| Cohort 3 Healthy Volunteers | Experimental | Drug: CoQ10 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide informed consent
- Male or female, age 18-70
- Ability to take an oral medication
- Willingness and ability to do electronic surveys
- Must have Crohn's disease for at least 3 months
Key exclusion criteria (20 listed)
- 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
- Chronic fatigue syndrome - noted in the medical record or self-reported
- Depression as measured with PROMIS Depression scale 7a with T score >=60
- New York Heart Association (NYHA) class 3 or greater heart failure - if noted in the medical record
- Untreated sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10The 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). | Drug | Cohort 1 Crohn's Disease Patients with Fatigue, Cohort 3 Healthy Volunteers |
Primary outcome
Assess improved fatigue among patients with Crohn's Disease
Time frame: 8 weeks
The primary objective of this study is to assess whether there is sufficient evidence of a change (greater than 7 points) in fatigue among patients with Crohn's disease taking CoQ10 to warrant conduct of a larger, placebo-controlled clinical trial. The primary outcome will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a, a unidimensional scale that has been well validated and tested among the general population and patients with IBD and many other chronic disorders. The scale ranges from 33.7 to 75.8. Higher scores indicate more greater fatigue.
1 secondary outcome
Change in domain specific fatigue
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided. Publication of the results of this study are planned. All publications emanating from this study will meet the authorship standards of the International Committee of Medical Journal Editors (ICMJE) standards. No data or samples obtained via this study will be shared with public repositories and there is no requirement to do so under the current funding mechanism for this study. If data or samples are shared with other investigators, they will be deidentified and the principal investigator will ensure that proper regulatory requirements are met before sharing the data. No data or samples will be provided outside of the University of Pennsylvania without an executed Material Transfer Agreement between the University of Pennsylvania and the institution receiving the data and or/samples.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CoQ10 in people with Crohn Disease and Healthy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess improved fatigue among patients with Crohn's Disease (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.