Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
Study NCT ID:
NCT04285450
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2019-10-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014812', 'term': 'Vitamin K'}], 'ancestors': [{'id': 'D009285', 'term': 'Naphthoquinones'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010836', 'term': 'Phytol'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-21', 'studyFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homeostasis model assessment of insulin resistance (HOMA-IR)', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '37552330', 'type': 'DERIVED', 'citation': 'Ali AM, Abbassi MM, Sabry NA, Fawzi M, Mousa S. The effect of vitamin K4 supplementation on insulin resistance in individuals with type 2 diabetes: a double-blind randomised placebo-controlled clinical trial. Eur J Nutr. 2023 Dec;62(8):3241-3249. doi: 10.1007/s00394-023-03215-8. Epub 2023 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the possible clinical effects associated with vitamin K supplementation on the glycemic control, insulin sensitivity and lipid profile of type II diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients 21-65 years old diagnosed with Type II diabetes.\n* Fasting blood glucose concentration ≥ 126 mg/dL .\n* Normal liver Function tests defined as ALT levels up to 33 U/L for males and up to 25 U/L for females, Albumin levels ≥ 3.5 g/dL, Bilirubin up to 1.1 mg/dL .\n* Normal clotting function defined as defined by INR.\n* Normal kidney function defined as serum creatinine values up to 1.3 mg/dL.\n\nExclusion Criteria:\n\n* Type I diabetic patients.\n* Use of supplements with potential effect on vitamin K level namely supplements containing vitamin K, co-enzyme Q10 or vitamin E \\> 400 IU .\n* Patients requiring anti-coagulant therapy including patients with prosthetic valves, mitral tissues, DVT, PE, atrial fibrillation and valvular heart disease.\n* Patient with history of coagulation, MI, stroke and embolization.\n* Pregnant or breast feeding women.\n* Being on hormonal therapy or receiving contraceptive pills.\n* Patients treated with glucocorticoids, thiazide diuretics, and atypical antipsychotics.\n* Patients on cholestyramine, antibiotics and coumarins.\n* Patients on lipid lowering agents.\n* Known intestinal malabsorption syndrome, cholestasis or steatorrhea.\n* Smokers.'}, 'identificationModule': {'nctId': 'NCT04285450', 'briefTitle': 'The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'CL2182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin K 1mg', 'interventionNames': ['Dietary Supplement: Vitamin K']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vitamin K', 'type': 'DIETARY_SUPPLEMENT', 'description': '1mg', 'armGroupLabels': ['Vitamin K 1mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Lactose', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Al Aini Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Amani Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}