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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419335
• Other study ID #: 855592
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Brittaney Bonhomme
• Phone: 2158982625
• Email: bobrit[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Healthy

Intervention

Drug:
• CoQ10
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	8 weeks