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Not yet recruiting NCT06962657

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

Phase II Interventional Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ubiquinone 100 mg Oral Soft Gel, Placebo.
Who it may be relevant to
Registry conditions: Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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. 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.
  • Drug 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. 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.

Primary outcome measures

  • 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.]
  • CoQ10 vs. placebo will (trend or effect) improve GSRH [Time frame: 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 [Time frame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.]
Secondary outcome measures (6)
  • Composite Adverse Health and Utilization Outcome 1 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.]
  • Preferred treatment phase [Time frame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UC San Diego — La Jolla

Identifiers

NCT: NCT06962657 · 812491

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗