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Набор скоро начнётся NCT06962657

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

Фаза II С лечением Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ubiquinone 100 mg Oral Soft Gel, Placebo.
Кому может быть актуально
Состояния в реестре: Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Препарат 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.
  • Препарат 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.

Первичные конечные точки

  • CoQ10 vs. placebo will (trend or effect) improve UCSD-20 (summed symptom score) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.]
Вторичные конечные точки (6)
  • Composite Adverse Health and Utilization Outcome 1 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.]
  • Preferred treatment phase [Срок оценки: Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UC San Diego — La Jolla

Идентификаторы

NCT: NCT06962657 · 812491

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗