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

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Completion pushed from Sep 1, 2026 to Jan 30, 2027 · Eligibility criteria expanded, about 23 words · Secondary endpoints: details revised at 1 of 1 entry Show 3 more changesShow less
    • Completion pushed from Sep 1, 2026 to Jan 30, 2027
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Completion pushed from Jun 1, 2026 to Sep 1, 2026v7
  3. Trial status changed: Enrolling by Invitation → Active, Not Recruitingv6
  4. Primary completion date: Dec 31, 2025 to Apr 30, 2026 Completion date: Mar 1, 2026 to Jun 1, 2026v5 Show 1 more changeShow less
    • Completion date: Mar 1, 2026 to Jun 1, 2026
  5. Primary completion date: Jun 1, 2025 to Dec 31, 2025 Completion date: Dec 1, 2025 to Mar 1, 2026v4 Show 1 more changeShow less
    • Completion date: Dec 1, 2025 to Mar 1, 2026
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  2. Start date: Jun 1, 2024 to Jul 20, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06419335
Lead Sponsor University of Pennsylvania
Conditions Crohn Disease, Healthy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov