Clinical trial NCT06962657: Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection
Official title: Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities
Keywords: Mixed toxic chemicals
Chronic multisymptom illness
Train derailment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: CoQ10 vs. placebo will (trend or effect) improve UCSD-20 (summed symptom score)
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: CoQ10 vs. placebo will (trend or effect) improve GSRH
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: CoQ10 vs. placebo will (trend or effect) improve timed chair rises
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
Secondary outcomes:
measure: Composite Adverse Health and Utilization Outcome 1
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Composite Adverse Health and Utilization Outcome 2
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Composite Adverse Health and Utilization Outcome 3
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Composite Adverse Health and Utilization Outcome 4
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Relation of change in primary outcomes to change in blood level of coenzyme Q10
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Preferred treatment phase
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
Other outcomes:
measure: Mitochondrial function from blood spot card
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Liver Function
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Inflammation (hsCRP)
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Urine organic acids
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: AM salivary pH will be less acidic on CoQ10 than placebo
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Salivary nitric oxide will be greater on active treatment than placebo
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Urine pH will be less acidic on active treatment than placebo
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
measure: Change in peak flow will be more favorable on active treatment than placebo
timeFrame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Beatrice A. Golomb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: