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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06962657
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Apr 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: CoQ10 Arm
    Ubiquinone soft gel 100mg/3x day
  • Placebo Comparator: Placebo Arm
    Soft gel placebo 3x/day

Primary Outcome Measure

CoQ10 vs. placebo will (trend or effect) improve UCSD-20 (summed symptom score) [ Time Frame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC San DiegoLa JollaCalifornia92093
Janis B. Ritchie, BSN
[email protected]
858-558-4950
Beatrice A. Golomb, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
UC San Diego· La Jolla, CA