Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT03111433
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-01', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in soluble interacellular adhesion molecule level', 'timeFrame': 'three months', 'description': 'it will be assessed at baseline and after three months of treatment'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes mellitus', 'Coenzyme Q10', 'endothelial dysfunction', 'pediatric patients'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: patients from 8 to 18 years old.\n2. Outpatient with at least 1 year history of type 1 diabetes mellitus.\n3. Insulin requirement of more than or equal 0.5 U/Kg/day.\n4. Approval to participate and give informed consent.\n\nExclusion Criteria:\n\n1. Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.\n2. Preexisting cardiovascular disease or hypertension.\n3. Chronic kidney disease or chronic liver disease.\n4. Significant mental illness.\n5. Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.\n6. Intake of coenzyme Q10 within the last 3 months.'}, 'identificationModule': {'nctId': 'NCT03111433', 'briefTitle': 'Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PHCL136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'this group of patients will receive their standard insulin treatment in addition to 100 mg of coenzyme Q10 soft gelatin capsule once daily for three month', 'interventionNames': ['Dietary Supplement: Coenzyme Q10', 'Drug: Insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'this group of patients will receive their standard insulin treatment only', 'interventionNames': ['Drug: Insulin']}], 'interventions': [{'name': 'Coenzyme Q10', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Coenzyme Q10 soft gelatin capsule 100mg', 'armGroupLabels': ['Group I']}, {'name': 'Insulin', 'type': 'DRUG', 'description': 'multiple dose insulin injection therapy', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': "Ainshams university pediatric's hospital", 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teaching assistant in clinical pharmacy department ,faculty of pharmacy , Ainshams university', 'investigatorFullName': 'Heba ibrahim Mohamed serag', 'investigatorAffiliation': 'Ain Shams University'}}}}