Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419335
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-27
First Post:
2024-05-07
Brief Title:
Reducing Fatigue With CoQ10 Supplementation in Patients With Crohns Disease Study
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Reducing Fatigue With CoQ10 Supplementation in Patients With Crohns Disease Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study includes an open label clinical trial comparing two doses of CoQ10 for 8 weeks to improve fatigue among patients with Crohns 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None