Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection

University of California San Diego

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities

Treatments: Dietary Supplement: Ubiquinone 100 mg Oral Soft Gel; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06962657

812491

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

CoQ10 Arm

Active Comparator group

Description:

Ubiquinone soft gel 100mg/3x day

Treatment:

Dietary Supplement: Ubiquinone 100 mg Oral Soft Gel

Placebo Arm

Placebo Comparator group

Description:

Soft gel placebo 3x/day

Treatment:

Dietary Supplement: Placebo