reducing fatigue with coq10 supplementation in patients with crohn's disease study

Conditions: Crohn Disease; Healthy

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) - \ 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