Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities
Conditions
Keywords
Mixed toxic chemicals, Chronic multisymptom illness, Train derailment
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.
Interventions
DRUGUbiquinone 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.
DRUGPlacebo
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.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CoQ10 vs. placebo will (trend or effect) improve UCSD-20 (summed symptom score) | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | CoQ10 vs. placebo will show (trend) improvement in dropouts for health related cause (e.g. not moved from area). |
| 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. | CoQ10 vs. placebo will show (trend) improvement in medical visits for cause (e.g. not routine annual follow up). |
| 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. | CoQ10 vs. placebo will show (trend) improvement in new health conditions/diagnoses/events. |
| 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. | CoQ10 vs. placebo will show (trend) improvement in new medications. |
| 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. | We predict that greater rise in CoQ10 blood levels (in ug/mL) will be tied to greater improvement in primary endpoints. |
| Preferred treatment phase | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. | 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). |
Countries
United States
Contacts
CONTACTJanis B. Ritchie, BSN
PRINCIPAL_INVESTIGATORBeatrice A. Golomb, MD, PhD
University of California, San Diego
Outcome results
None listed