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

NCT06419335 | Enrolling By Invitation Early Phase 1

• 1 other identifier: 855592
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.CoQ10 will improve quality of life as measured with the short Inflammatory Bowel Disease Questionnaire (sIBDQ).

Conditions

Crohn Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in domain specific fatigue

  8 weeks

Study Arms (3)

Cohort 1 Crohn's Disease Patients with Fatigue

EXPERIMENTAL

Drug: CoQ10

Cohort 2 Crohn's Disease without Fatigue

NO INTERVENTION

Cohort 3 Healthy Volunteers

EXPERIMENTAL

Drug: CoQ10

Interventions

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).

Cohort 1 Crohn's Disease Patients with Fatigue; Cohort 3 Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• \. Prescreening PROMIS Fatigue 7a T score \<55

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 17, 2024
• Study Start: July 20, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

US (1)