Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-29 @ 1:03 AM
Study NCT ID:
NCT07096557
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mitochondrial dysfunction', 'timeFrame': '3 months', 'description': 'Through assessment of NLRP3 Inflammasome and Type 1 INF (INF α).'}], 'secondaryOutcomes': [{'measure': 'systemic lupus erythematosus disease activity index (SLEDAI) score.', 'timeFrame': '3 months', 'description': 'Determine its possible beneficial effect on disease activity through assessment of systemic lupus erythematosus disease activity index (SLEDAI) score.'}, {'measure': 'The safety and tolerability of Coenzyme Q10', 'timeFrame': '3 months', 'description': 'Assess the safety and tolerability of Coenzyme Q10 supplementation in pediatric SLE patients.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to evaluate the efficacy and safety of coenzyme Q10 supplementation in pediatric patients with SLE. The main questions it aims to answer are:\n\n* What the impact of coenzyme Q10 supplementation on mitochondrial dysfunction?\n* Does it have beneficial effect on disease activity through assessment of systemic lupus erythematosus disease activity index (SLEDAI) score?\n\nResearchers will compare the group of patients that take coenzyme Q10 to a group that doesn't to see if coenzyme Q10 supplementation works to decrease mitochondrial dysfunction and disease activity.\n\nParticipants will:\n\nTake coenzyme Q10 plus standard treatment of SLE or the standard treatment only every day for 3 months.\n\nVisit the clinic once every 4 weeks for checkups and tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both genders aged 6-16 years old diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria of SLE.\n2. Patients with moderate to severe activity presenting with lupus nephritis.\n3. No enrollment in any other clinical trial.\n4. Judged by the physician to be physically stable.\n\nExclusion Criteria:\n\n1. Patients taking over-the-counter antioxidants such as N-acetylcysteine, vitamin E, omega-3 fatty acids, L-carnitine or vitamin C that can enhance the effect of CoQ10.\n2. Patients with very severe active SLE that might threaten vital organs.\n3. Patients with chronic infections, severe and recurrent infections whether bacterial, viral, or fungal infection'}, 'identificationModule': {'nctId': 'NCT07096557', 'briefTitle': 'The Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'RHDIRB2020110301 REC #272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coenzyme Q10 group', 'description': 'Group 1 (Coenzyme Q10 group): consists of 30 patients who will receive one capsule containing 100 mg Coenzyme Q10 once daily for 12 weeks, "Coenzyme Q10 Forte® ".', 'interventionNames': ['Drug: Coenzyme Q10']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Group 2 (Control group): consists of 30 patients who will not receive the intervention.'}], 'interventions': [{'name': 'Coenzyme Q10', 'type': 'DRUG', 'description': 'Coenzyme Q10 100 mg capsule once daily for 3 months', 'armGroupLabels': ['Coenzyme Q10 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'The Pediatric Allergy, Immunology and Rheumatology Unit, Ain Shams University Hospitals.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mariam helal kaiser', 'role': 'CONTACT', 'email': 'mariam.helal@pharma.asu.edu.eg', 'phone': '01274712898'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator of clinical pharmacy department at faculty of pharmacy Ain shams university', 'investigatorFullName': 'Helal', 'investigatorAffiliation': 'Ain Shams University'}}}}