CoQ10 for Fatigue in Crohn's Disease

Overseen By Lisa Nessel

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Pennsylvania

Must not be taking: Corticosteroids, Warfarin

Disqualifiers: Pregnancy, Chronic fatigue, Depression, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial requires that participants have been on a stable medication regimen for Crohn's disease for at least 4 weeks, so you should not stop your current medications. However, you cannot participate if you are taking systemic corticosteroids or warfarin.

Is CoQ10 safe for humans?

The provided research articles do not contain specific safety data on CoQ10 (Ubiquinone, Coenzyme Q10) for humans. ^{1 2 3 4 5}

How does the treatment CoQ10 for fatigue in Crohn's Disease differ from other treatments?

CoQ10 is unique because it is a natural antioxidant that helps improve energy production in cells, which may reduce fatigue by addressing mitochondrial dysfunction, a potential issue in Crohn's Disease. Unlike standard treatments for Crohn's, which often focus on reducing inflammation, CoQ10 targets energy metabolism and oxidative stress, offering a novel approach to managing fatigue. ^{6 7 8 9 10}

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for adults aged 18-70 with Crohn's disease who have been stable on their medication for at least a month and are not currently experiencing severe symptoms. Participants must be able to take oral meds and complete electronic surveys. There's also a group of healthy volunteers taking CoQ10.

Inclusion Criteria

I can take pills by mouth.

Prescreening PROMIS Fatigue 7a T score <55 (Cohort 2 and Cohort 3)

I have been on a stable Crohn's disease medication for at least 4 weeks.

Exclusion Criteria

I have been diagnosed with or reported having chronic fatigue syndrome.

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

I have sleep apnea that has not been treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CoQ10 supplementation for 8 weeks to improve fatigue among patients with Crohn's disease

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CoQ10

Trial Overview The study tests two different doses of CoQ10 over an 8-week period in Crohn's patients, aiming to reduce fatigue as measured by the PROMIS Fatigue instrument and improve quality of life via the sIBDQ questionnaire. Healthy controls will take CoQ10 for two weeks.

Participant Groups

Group I: Cohort 3 Healthy Volunteers Experimental Treatment 1 Intervention

Group II: Cohort 1 Crohn's Disease Patients with Fatigue Experimental Treatment 1 Intervention

Group III: Cohort 2 Crohn's Disease without Fatigue Active Control 1 Intervention

CoQ10 is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as CoQ10 for:

• Dietary supplement for mitochondrial support

Approved in European Union as CoQ10 for:

• Dietary supplement for energy metabolism support

Approved in Canada as CoQ10 for:

• Natural health product for antioxidant support

Approved in Japan as CoQ10 for:

• Food for specified health uses for heart health support

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

References

1. England pubmed.ncbi.nlm.nih.gov

B-vitamins, related vitamers, and metabolites in patients with quiescent inflammatory bowel disease and chronic fatigue treated with high dose oral thiamine. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Multiple vitamin status in Crohn's disease. Correlation with disease activity. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Antioxidant vitamin supplementation in Crohn's disease decreases oxidative stress. a randomized controlled trial. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Unmet Needs in IBD: the Case of Fatigue. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Perceived acceptability of partial enteral nutrition (PEN) using oral nutritional supplement drinks in adolescent and adult Crohn's disease outpatients: A feasibility study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Does oral coenzyme Q10 plus NADH supplementation improve fatigue and biochemical parameters in chronic fatigue syndrome? [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Genetics of coenzyme q10 deficiency. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Coenzyme Q10 Supplementation for Reducing Fatigue: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 and colorectal neoplasms in aged patients. [2004]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Short-term ubiquinol-10 supplementation alleviates tissue damage in muscle and fatigue caused by strenuous exercise in male distance runners. [2021]