Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and ComorbiditiesPhase 2NCT06962657
Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection
A Phase 2 study testing Ubiquinone 100 mg Oral Soft Gel in people with Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities
- What is being tested?
- Ubiquinone 100 mg Oral Soft Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UC San Diego
La Jolla, California, 92093
Janis B. Ritchie, BSN, 858-558-4950, golombresearch@ucsd.edu
Beatrice A. Golomb, MD, PhD
About this study
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.
- Being tested
- Ubiquinone 100 mg Oral Soft Gel, Placebo
- Keywords
- Mixed toxic chemicals, Chronic multisymptom illness, Train derailment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ubiquinone 100 mg Oral Soft GelDrug
Also called Coenzyme Q10
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| CoQ10 Arm | Active comparator | Ubiquinone soft gel 100mg/3x day Receives: Drug: Ubiquinone 100 mg Oral Soft Gel |
| Placebo Arm | Placebo comparator | Soft gel placebo 3x/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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
CoQ10 vs. placebo will show (trend) improvement in dropouts for health related cause (e.g. not moved from area).
Measured: 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
CoQ10 vs. placebo will show (trend) improvement in medical visits for cause (e.g. not routine annual follow up).
Measured: 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
CoQ10 vs. placebo will show (trend) improvement in new health conditions/diagnoses/events.
Measured: 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
CoQ10 vs. placebo will show (trend) improvement in new medications.
Measured: 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
We predict that greater rise in CoQ10 blood levels (in ug/mL) will be tied to greater improvement in primary endpoints.
Measured: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
Preferred treatment phase
More participants will "prefer" (perceive greater benefit from) the phase in which they received active (CoQ10) vs placebo treatment, assessed at still-blinded final visit (sign test).
Measured: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start15 May 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and ComorbiditiesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatrice Golomb, University of California, San Diego
- Investigators
- Beatrice A. Golomb, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962657
- Sponsor's protocol ID
- 812491
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection
- ClinicalTrials.gov ID
- NCT06962657
- Acronym / sponsor ID
- 812491
- Keywords
- Mixed toxic chemicals, Chronic multisymptom illness, Train derailment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoQ10 Arm | Active comparator | Drug: Ubiquinone 100 mg Oral Soft GelUbiquinone soft gel 100mg/3x day |
| Placebo Arm | Placebo comparator | Drug: PlaceboSoft gel placebo 3x/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ubiquinone 100 mg Oral Soft GelAlso: Coenzyme Q10Active 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 | CoQ10 Arm |
| PlaceboPlacebo 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. | Drug | Placebo Arm |
Primary outcome
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.
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).
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.
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.
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.
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).
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatrice A. Golomb, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ubiquinone 100 mg Oral Soft Gel in people with Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janis B. Ritchie, BSN (858-558-4950, jbritchie@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.