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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Crohn's Disease Patients with Fatigue | Experimental |
| |
| Cohort 2 Crohn's Disease without Fatigue | No Intervention | ||
| Cohort 3 Healthy Volunteers | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoQ10 | Drug | The core component of this pilot study will be a single center open label randomized trial comparing low dose and high dose CoQ10 among 30 patients with Crohn's disease and fatigue (Cohort 1) and 15 healthy volunteers (Cohort 3). |
| Measure | Description | Time Frame |
|---|---|---|
| Assess improved fatigue among patients with Crohn's Disease | The primary objective of this study is to assess whether there is sufficient evidence of a change (greater than 7 points) in fatigue among patients with Crohn's disease taking CoQ10 to warrant conduct of a larger, placebo-controlled clinical trial. The primary outcome will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a, a unidimensional scale that has been well validated and tested among the general population and patients with IBD and many other chronic disorders. The scale ranges from 33.7 to 75.8. Higher scores indicate more greater fatigue. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in domain specific fatigue | Secondary outcome measures will include improvement in domain specific fatigue, overall fatigue assessed with a different unidimensional scale using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) for changes in Inflammatory Bowel Disease(IBD)-related quality of life. The scale ranges from 0 to 52. Higher scores indicate better quality of life. |
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Inclusion Criteria for all study participants
To be eligible for this study all study participants must meet the following:
Additional inclusion criteria for Cohort 1 and Cohort 2 participants:
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
Exclusion Criteria for Cohorts 1 and 3
1. Previous intolerance to CoQ10
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Publication of the results of this study are planned. All publications emanating from this study will meet the authorship standards of the International Committee of Medical Journal Editors (ICMJE) standards.
No data or samples obtained via this study will be shared with public repositories and there is no requirement to do so under the current funding mechanism for this study.
If data or samples are shared with other investigators, they will be deidentified and the principal investigator will ensure that proper regulatory requirements are met before sharing the data. No data or samples will be provided outside of the University of Pennsylvania without an executed Material Transfer Agreement between the University of Pennsylvania and the institution receiving the data and or/samples.
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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| 8 weeks |
| D007410 | Intestinal Diseases |