Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection
- Conditions
- Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities
- Registration Number
- NCT06962657
- Lead Sponsor
- University of California, San Diego
- Brief Summary
This research study is being conducted to see if coenzyme Q10 (a nutritional supplement) might help to prevent and/or alleviate symptoms and health consequences and help to improve quality of life and physical function in residents affected by the February 2023 East Palestine, Ohio train derailment. This is a pilot study that is not powered to achieve benefit but seek to examine effect size and variance to aid in power calculations for a potential future better powered study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- On Feb. 3, 2023, lived within 10 miles of the East Palestine, OH train derailment (closer in will receive preference). Others who were in the area for toxin mitigation and other reasons and show compatible symptoms will also be eligible.
- Meets Kansas symptom criteria for multi-symptom illness - originally defined for Gulf War Illness (has persistent symptoms, lasting greater than six months, that are of >mild severity in at least three of the six domains of fatigue/sleep, pain, neurological/cognitive/mood, gastrointestinal, respiratory and dermatologic). At least some symptoms must be new or worsened since the derailment.
- Access to internet and smart phone or computer for remote Qualtrics survey participation.
- Willing to perform the stipulated study elements.
- Took ≥80% of run-in soft gels.
- Anticipated move from the area or other anticipated obstacle to participating for study duration.
- Participating in another clinical trial.
- Has a pre-existing health condition expected to produce significant and variable fluctuating symptoms (e.g. chronic infection and/or active cancer other than non-melanoma skin cancer).
- Contraindications to CoQ10, such as use of coumadin (although an interaction with CoQ10 is controversial).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method CoQ10 vs. placebo will (trend or effect) improve UCSD-20 (summed symptom score) Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. on placebo. Outcomes are assessed as change from start of that treatment phase (from baseline for phase 1; and from 3 month crossover visit for phase 2).
CoQ10 vs. placebo will (trend or effect) improve GSRH Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. Mean change in single-item General Self-Rated Health (GSRH). Outcomes are assessed as change from start of that treatment phase (from baseline for phase 1; and from 3 month crossover visit for phase 2). 5 point scale, higher is good.
CoQ10 vs. placebo will (trend or effect) improve timed chair rises Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score. Outcomes are assessed as change from start of that treatment phase (from baseline for phase 1; and from 3 month crossover visit for phase 2).
- Secondary Outcome Measures
Name Time Method Composite Adverse Health and Utilization Outcome 1 Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. CoQ10 vs. placebo will show (trend) improvement in dropouts for health related cause (e.g. not moved from area).
Composite Adverse Health and Utilization Outcome 2 Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. CoQ10 vs. placebo will show (trend) improvement in medical visits for cause (e.g. not routine annual follow up).
Composite Adverse Health and Utilization Outcome 3 Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. CoQ10 vs. placebo will show (trend) improvement in new health conditions/diagnoses/events.
Composite Adverse Health and Utilization Outcome 4 Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. CoQ10 vs. placebo will show (trend) improvement in new medications.
Relation of change in primary outcomes to change in blood level of coenzyme Q10 Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. We predict that greater rise in CoQ10 blood levels (in ug/mL) will be tied to greater improvement in primary endpoints.
Preferred treatment phase Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. More participants will "prefer" (perceive greater benefit from) the phase in which they received active (CoQ10) vs placebo treatment, assessed at still-blinded final visit (sign test).
Trial Locations
- Locations (1)
UC San Diego
🇺🇸La Jolla, California, United States