Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT05170893
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2021-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'D014451', 'term': 'Ubiquinone'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2021-12-11', 'studyFirstSubmitQcDate': '2021-12-11', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Malondialdehyde (MDA)', 'timeFrame': '12 weeks', 'description': 'marker of oxidative stress'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis']}, 'descriptionModule': {'briefSummary': 'All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation. Coenzyme Q10 is a vitamin-like antioxidant synthesized in almost all body cells, and it is also available in many dietary sources. It was observed that chronic kidney disease patients have low plasma levels of Coenzyme Q10. Clinical benefits of Coenzyme Q10 supplementation have been documented for various cardiovascular and neurodegenerative disorders. The investigators believe that Coenzyme Q10 supplementation may have potential benefits in pediatric patients receiving hemodialysis; mainly due to its antioxidant activity and anti-inflammatory effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients with ages between 2 to 18 years old.\n* Undergoing regular hemodialysis for at least 6 months.\n\nExclusion Criteria:\n\n* Patients who weigh less than 10 kg.'}, 'identificationModule': {'nctId': 'NCT05170893', 'briefTitle': 'Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'ACUC-FP-ASU RHDIRB2020110301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Oral Coenzyme Q10 capsules daily for 12 weeks.', 'interventionNames': ['Dietary Supplement: Coenzyme Q10']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Oral capsules similar to the intervention daily for 12 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Coenzyme Q10', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ubiquinone, ubidecarenone, ubiquitous quinone'], 'description': 'Oral capsules', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral capsules', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': "El-Demerdash Children's Hospital", 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Salma AbdelRahman', 'investigatorAffiliation': 'Misr International University'}}}}