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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether CoQ10, a supplement, can reduce fatigue in people with Crohn's disease. It compares two doses over eight weeks to determine if a higher dose provides more relief. Participants with Crohn's who experience fatigue and have had the condition for at least three months may be suitable candidates. The study also includes healthy volunteers taking CoQ10 for two weeks to compare results. As an Early Phase 1 trial, this research aims to understand how CoQ10 works in people, offering participants a chance to contribute to groundbreaking insights.

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 there any evidence suggesting that CoQ10 is likely to be safe for humans?

Research has shown that CoQ10 is generally safe for most people, with few side effects. It may help reduce gut inflammation in animals with inflammatory bowel disease (IBD). Although limited safety data exists for humans, one study found that a person with ulcerative colitis (a type of IBD) who took 200 mg of CoQ10 daily for 8 weeks experienced improved symptoms without any reported side effects. This finding is encouraging, but consulting a healthcare provider before starting any new supplement is always best. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease fatigue?

Most treatments for Crohn's disease focus on reducing inflammation using medications like corticosteroids or immunosuppressants. But CoQ10 works differently by targeting cellular energy production. Researchers are excited about CoQ10 because it's a natural antioxidant that might help reduce fatigue, a common issue for many with Crohn's disease, by improving how cells produce and use energy. This approach offers a novel way to potentially address fatigue without the side effects associated with traditional anti-inflammatory drugs.

What evidence suggests that CoQ10 might be an effective treatment for fatigue in Crohn's disease?

Research has shown that CoQ10 might help reduce tiredness in people with autoimmune conditions. One study found that patients who took 100 mg of CoQ10 daily for three months felt less tired. Another study showed that CoQ10 improved the quality of life and reduced the severity of symptoms in patients with ulcerative colitis, a condition similar to Crohn's disease. CoQ10 helps by lowering oxidative stress, which can cause tiredness. This trial will evaluate CoQ10 in different cohorts, including those with Crohn's disease with and without fatigue, and healthy volunteers, to determine its potential to reduce fatigue and improve overall well-being in people with Crohn's disease. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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

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

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

I am currently taking warfarin.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/early-phase-1-crohn-disease-5-2024-fd9f0

CoQ10 for Fatigue in Crohn's Disease · Info for Participants 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11049925/

Coenzyme Q10 and Autoimmune Disorders: An Overview In a study comprising 44 patients with RA, supplementation with CoQ10 (100 mg/day for 3 months) reduced the levels of oxidative stress and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8111632/

Effects of coenzyme Q10 on health-related quality of life ... Findings suggest that CoQ10 can be used as a potential intervention for diminishing the disease severity and blood pressure and may improve QoL and UC patients.

4. ctv.veeva.com ctv.veeva.com/study/reducing-fatigue-with-coq10-supplementation-in-patients-with-crohns-disease-study

Reducing Fatigue With CoQ10 Supplementation in Patients ... 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.

5. mdpi.com mdpi.com/1422-0067/25/1/574

Mitochondrial Dysfunction and Coenzyme Q10 ... [86] reported CoQ10 supplementation (100 mg/day for 3 months) significantly improved fatigue. In an open-label crossover study, supplementation with a water- ...

6. mayoclinic.org mayoclinic.org/drugs-supplements-coenzyme-q10/art-20362602

Coenzyme Q10 Most healthcare professionals think CoQ10 is safe, with few side effects. But ask your healthcare professional before you take the supplement.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1567576925015206

Mitochondrial targeting of coenzyme Q10 in inflammatory ... Preclinical studies and preliminary clinical trials have confirmed that CoQ10 supplementation can alleviate intestinal inflammation in IBD model animals, reduce ...

8. nmi.health nmi.health/inflammatory-bowel-disease-towards-a-model-for-personalised-nutritional-therapy/

Inflammatory Bowel Disease: Towards a Model for ... In a clinical trial, a patient with UC who received CoQ10 (200 mg daily) for 8 weeks had a significant reduction in symptom scores and blood ...