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

NCT06962657 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 812491
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities

Keywords

Mixed toxic chemicals; Chronic multisymptom illness; Train derailment

Outcome Measures

Primary Outcomes (3)

• CoQ10 vs. placebo will (trend or effect) improve UCSD-20 (summed symptom score)

  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).

  Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.

• CoQ10 vs. placebo will (trend or effect) improve GSRH

  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.

  Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.

• CoQ10 vs. placebo will (trend or effect) improve timed chair rises

  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).

  Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.

Secondary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Other Outcomes (8)

• Mitochondrial function from blood spot card

  Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.

• Liver Function

  Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.

• Inflammation (hsCRP)

  Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.

Study Arms (2)

CoQ10 Arm

ACTIVE COMPARATOR

Ubiquinone soft gel 100mg/3x day

Drug: Ubiquinone 100 mg Oral Soft Gel

Placebo Arm

PLACEBO COMPARATOR

Soft gel placebo 3x/day

Drug: Placebo

Interventions

Ubiquinone 100 mg Oral Soft Gel DRUG

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. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.

Also known as: Coenzyme Q10

CoQ10 Arm

Placebo DRUG

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. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Interventions

Ubiquinone; coenzyme Q10

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Study Officials

• Beatrice A. Golomb, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janis B. Ritchie, BSN

CONTACT

858-558-4950; jbritchie@ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: May 8, 2025
• Study Start: May 15, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)