Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT06962657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2025-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014451', 'term': 'Ubiquinone'}, {'id': 'C024989', 'term': 'coenzyme Q10'}], 'ancestors': [{'id': 'D016227', 'term': 'Benzoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-05', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mitochondrial function from blood spot card', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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.'}, {'measure': 'Liver Function', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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.'}, {'measure': 'Inflammation (hsCRP)', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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.'}, {'measure': 'Urine organic acids', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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.'}, {'measure': 'AM salivary pH will be less acidic on CoQ10 than placebo', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.'}, {'measure': 'Salivary nitric oxide will be greater on active treatment than placebo', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.'}, {'measure': 'Urine pH will be less acidic on active treatment than placebo', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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.'}, {'measure': 'Change in peak flow will be more favorable on active treatment than placebo', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.'}], 'primaryOutcomes': [{'measure': 'CoQ10 vs. placebo will (trend or effect) improve UCSD-20 (summed symptom score)', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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).'}, {'measure': 'CoQ10 vs. placebo will (trend or effect) improve GSRH', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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.'}, {'measure': 'CoQ10 vs. placebo will (trend or effect) improve timed chair rises', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Composite Adverse Health and Utilization Outcome 1', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': 'CoQ10 vs. placebo will show (trend) improvement in dropouts for health related cause (e.g. not moved from area).'}, {'measure': 'Composite Adverse Health and Utilization Outcome 2', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': 'CoQ10 vs. placebo will show (trend) improvement in medical visits for cause (e.g. not routine annual follow up).'}, {'measure': 'Composite Adverse Health and Utilization Outcome 3', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': 'CoQ10 vs. placebo will show (trend) improvement in new health conditions/diagnoses/events.'}, {'measure': 'Composite Adverse Health and Utilization Outcome 4', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': 'CoQ10 vs. placebo will show (trend) improvement in new medications.'}, {'measure': 'Relation of change in primary outcomes to change in blood level of coenzyme Q10', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': 'We predict that greater rise in CoQ10 blood levels (in ug/mL) will be tied to greater improvement in primary endpoints.'}, {'measure': 'Preferred treatment phase', 'timeFrame': 'Outcomes will be assessed at run-in (1-2 weeks before baseline) and baseline, and ~3 and ~6 months.', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mixed toxic chemicals', 'Chronic multisymptom illness', 'Train derailment'], 'conditions': ['Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* Access to internet and smart phone or computer for remote Qualtrics survey participation.\n* Willing to perform the stipulated study elements.\n* Took ≥80% of run-in soft gels.\n\nExclusion Criteria:\n\n* Anticipated move from the area or other anticipated obstacle to participating for study duration.\n* Participating in another clinical trial.\n* 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).\n* Contraindications to CoQ10, such as use of coumadin (although an interaction with CoQ10 is controversial).'}, 'identificationModule': {'nctId': 'NCT06962657', 'briefTitle': 'Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection', 'orgStudyIdInfo': {'id': '812491'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CoQ10 Arm', 'description': 'Ubiquinone soft gel 100mg/3x day', 'interventionNames': ['Dietary Supplement: Ubiquinone 100 mg Oral Soft Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Soft gel placebo 3x/day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Ubiquinone 100 mg Oral Soft Gel', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Coenzyme Q10'], 'description': '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.', 'armGroupLabels': ['CoQ10 Arm']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Janis B. Ritchie, BSN', 'role': 'CONTACT', 'email': 'golombresearch@ucsd.edu', 'phone': '858-558-4950'}, {'name': 'Beatrice A. Golomb, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Janis B. Ritchie, BSN', 'role': 'CONTACT', 'email': 'jbritchie@ucsd.edu', 'phone': '858-558-4950'}], 'overallOfficials': [{'name': 'Beatrice A. Golomb, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Beatrice Golomb', 'investigatorAffiliation': 'University of California, San Diego'}}}}