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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2028-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CoQ10 Arm

Ubiquinone soft gel 100mg/3x day

Group Type ACTIVE_COMPARATOR

Ubiquinone 100 mg Oral Soft Gel

Intervention Type DIETARY_SUPPLEMENT

Active comparator arm receives three ubiquinone 100mg soft gels per day. Supplement is taken orally in divided doses, with the last soft gel not close to bedtime.

Placebo Arm

Soft gel placebo 3x/day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo comparator arm receives three placebo soft gels per day. Supplement is taken orally in divided doses, with the last soft gel not close to bedtime.

Interventions

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Ubiquinone 100 mg Oral Soft Gel

Active comparator arm receives three ubiquinone 100mg soft gels per day. Supplement is taken orally in divided doses, with the last soft gel not close to bedtime.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo comparator arm receives three placebo soft gels per day. Supplement is taken orally in divided doses, with the last soft gel not close to bedtime.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Coenzyme Q10

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No