Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study

Inclusion criteria

for all study participants

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:

• 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

• Prescreening PROMIS Fatigue 7a T score >60 5.4 Additional inclusion criteria for Cohort 2 and 3

• Prescreening PROMIS Fatigue 7a T score <55

Exclusion criteria

- for all study participants

• 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
• 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

Exclusion criteria

for Cohorts 1 and 3

• Previous intolerance to CoQ10