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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoQ10 Arm | Active Comparator | Ubiquinone soft gel 100mg/3x day |
|
| Placebo Arm | Placebo Comparator | Soft gel placebo 3x/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial function from blood spot card | Maximal respiration and spare capacity will be assessed by the "adopted transfer" technique. This uses Seahorse technology to look at mitochondrial function. Note this is an exploratory outcome, which means we will be exploring what can be seen, so it is not a primary or secondary aim. | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janis B. Ritchie, BSN | Contact | 858-558-4950 | jbritchie@ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Beatrice A. Golomb, MD, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093 | United States |
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| ID | Term |
|---|---|
| D014451 | Ubiquinone |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D016227 | Benzoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D003067 | Coenzymes |
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|
| 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. |
|
CoQ10 vs. placebo will show (trend) improvement in medical visits for cause (e.g. not routine annual follow up). |
| 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. | 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. | 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. | 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). | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
| Liver Function | Alanine aminotransferase and aspartate aminotransferase will be assessed as change from start of that treatment phase (from baseline for phase 1; and from 3 month crossover visit for phase 2) and compared on active treatment vs. placebo. | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
| Inflammation (hsCRP) | Inflammation (hsCRP) will be assessed as change from start of that treatment phase (from baseline for phase 1; and from 3 month crossover visit for phase 2) and compared on active treatment vs. placebo. | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
| Urine organic acids | Change in 8-OHdG will be more favorable (i.e. lower 8-OHdG) on active treatment than placebo. Urine organic acid abnormalities that relate to mitochondrial impairment (specifics of these will be different for different participants) will show favorable change on active treatment vs placebo. | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
| AM salivary pH will be less acidic on CoQ10 than placebo | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
| Salivary nitric oxide will be greater on active treatment than placebo | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
| Urine pH will be less acidic on active treatment than placebo | Urine pH (preferred measurement time is at least 4 hours after the last meal -- ideally after lunch) will be less acidic on active treatment than placebo. | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
| Change in peak flow will be more favorable on active treatment than placebo | Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months. |
| D045762 |
| Enzymes and Coenzymes |