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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
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.
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.
UC San Diego
La Jolla, California, United States
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).
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
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.
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
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).
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 1
CoQ10 vs. placebo will show (trend) improvement in dropouts for health related cause (e.g. not moved from area).
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
CoQ10 vs. placebo will show (trend) improvement in medical visits for cause (e.g. not routine annual follow up).
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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
CoQ10 vs. placebo will show (trend) improvement in new health conditions/diagnoses/events.
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
CoQ10 vs. placebo will show (trend) improvement in new medications.
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
We predict that greater rise in CoQ10 blood levels (in ug/mL) will be tied to greater improvement in primary endpoints.
Time frame: 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).
Time frame: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.