Clinical trial NCT06419335: Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study
Official title: Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Crohn Disease
Healthy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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: 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

Primary outcomes:
measure: Assess improved fatigue among patients with Crohn's Disease
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in domain specific fatigue
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: