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NCT06419335 · ClinicalTrials.gov registry record · Early Phase 1
Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study
A Early Phase 1 study, sponsored by University of Pennsylvania.
- Active
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
NCT06419335: Active Early Phase 1 study, sponsored by University of Pennsylvania.
NCT06419335 is a Early Phase 1 study that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 60 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06419335, a Early Phase 1 study, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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).
Primary Outcome
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 othe
Interventions
- DRUG CoQ10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-07-20 |
| Est. Completion | 2026-09-01 |
| Phase | Early Phase 1 |
What the registry record for NCT06419335 still lists
NCT06419335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 1 intervention - of which CoQ10 is the first listed.
NCT06419335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06419335 about?
NCT06419335 is a clinical study titled "Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study". 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 ...
What is the current status of trial NCT06419335?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2024-07-20. Estimated completion is 2026-09-01.
What interventions are being tested in trial NCT06419335?
The interventions under investigation include: CoQ10 (DRUG).
Who is sponsoring clinical trial NCT06419335?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06419335's enrollment target sits among peer trials
60 403rd of 2000 higher than 1,565 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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