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Antioxidant
CoQ10 for Fatigue in Crohn's Disease
Phase < 1
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, age 18-70
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 (Cohort 1 and Cohort 2)
Must not have
Chronic fatigue syndrome - noted in the medical record or self-reported
Untreated sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the effectiveness of two different doses of CoQ10 in reducing fatigue in patients with Crohn's disease. They will also study the effects of CoQ10 on healthy individuals.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
CoQ10 is generally well-tolerated but can sometimes cause mild side effects like upset stomach, loss of appetite, nausea, diarrhea, or allergic skin rashes in some individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
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My Crohn's disease is under control, with minimal diarrhea and pain.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with or reported having chronic fatigue syndrome.
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I have sleep apnea that has not been treated.
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I have been diagnosed with Multiple Sclerosis.
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I am currently taking warfarin.
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My medical records show I have advanced heart failure.
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I have low iron levels or anemia according to my blood tests.
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I take medication for my diabetes.
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My kidney function is reduced, with an eGFR below 45 ml/min.
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I have been diagnosed with cirrhosis.
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I have been diagnosed with primary sclerosing cholangitis.
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I have hepatitis C that has not been successfully treated.
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I am currently undergoing chemotherapy for cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assess improved fatigue among patients with Crohn's Disease
Secondary study objectives
Change in domain specific fatigue
Side effects data
From 2021 Phase 2 trial • 216 Patients • NCT031337936%
Urinary Tract Infection
3%
Heart Failure
3%
Soft tissue infection
3%
Pneumonitis
3%
Lung Infection
3%
Diarrhea
3%
Skin infection
3%
Non-cardiac chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
CoQ10 + D-ribose
Placebo Only
CoQ10 Only
D-ribose Only
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 3 Healthy VolunteersExperimental Treatment1 Intervention
Group II: Cohort 1 Crohn's Disease Patients with FatigueExperimental Treatment1 Intervention
Group III: Cohort 2 Crohn's Disease without FatigueActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CoQ10
2010
Completed Phase 3
~400
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,727,270 Total Patients Enrolled