Cure8 trial brief
Fatigue is a common, impactful symptom in Crohn's disease with limited targeted treatments. This early-phase trial is testing whether CoQ10 supplements might reduce fatigue and could inform larger placebo-controlled studies.
Adults with Crohn's disease who experience fatigue, IBD clinicians interested in symptom-targeted trials, and researchers studying fatigue interventions or nutritional supplements.
This is a registered early-phase interventional trial (NCT06419335) testing oral coenzyme Q10 (CoQ10) in adults with Crohn's disease and fatigue. The core design is an open-label randomized comparison of low- versus high-dose CoQ10 over 8 weeks in Crohn's patients with fatigue, plus cohorts of Crohn's patients without fatigue and healthy volunteers.
The primary outcome is change in fatigue measured by PROMIS Fatigue 7a; planned enrollment is 60 and the study is active-not-recruiting at the University of Pennsylvania. The record lists detailed inclusion/exclusion criteria, safety-related lab cutoffs, and secondary sample collections (blood and urine CoQ10 levels).
This is a pilot/early-phase study intended to determine whether a larger, placebo-controlled trial is warranted, not to provide definitive evidence on effectiveness.
If you have Crohn's disease and are interested in fatigue treatments, this trial describes a research opportunity and measurements used to evaluate fatigue, but it does not present results or clinical recommendations.
This is an early-phase, open-label pilot study without reported results in the registry record. Because it is not randomized against placebo and is small, any future positive findings would need confirmation in larger, placebo-controlled trials before changing clinical care.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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