Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
Study NCT ID:
NCT04145492
Status:
UNKNOWN
Last Update Posted:
2019-10-30
First Post:
2019-10-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D024482', 'term': 'Vitamin K 2'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002112', 'term': 'Calcifediol'}], 'ancestors': [{'id': 'D014812', 'term': 'Vitamin K'}, {'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': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-29', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncarboxylated MGP', 'timeFrame': '4 months', 'description': 'Measuring serum level of Uncarboxylated MGP as a marker for calcification'}, {'measure': 'Uncarboxylated osteocalcin', 'timeFrame': '4 months', 'description': 'Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis and Vitamin K2'], 'conditions': ['End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '34845313', 'type': 'DERIVED', 'citation': 'El Borolossy R, El-Farsy MS. The impact of vitamin K2 and native vitamin D supplementation on vascular calcification in pediatric patients on regular hemodialysis. A randomized controlled trial. Eur J Clin Nutr. 2022 Jun;76(6):848-854. doi: 10.1038/s41430-021-01050-w. Epub 2021 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.', 'detailedDescription': "Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries \\[3, 4\\]. It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.\n\nThe aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients aged 6-18 years\n* Patients on hemodialysis since 3 months or longer\n* Hemodialysis frequency 3 times or more weekly\n\nExclusion criteria:\n\n* Patients with life expectancy \\< 3 months\n* Patients taking warfarin\n* Patients with known intestinal malabsorption'}, 'identificationModule': {'nctId': 'NCT04145492', 'briefTitle': 'Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Impact of Vitamin K2 and Inactive Vitamin D Supplementation on Vascular Calcification in Pediatric Patients on Regular Hemodialysis', 'orgStudyIdInfo': {'id': '12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin K2 group', 'description': '15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.', 'interventionNames': ['Drug: Vitamin K2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cholecalciferol group', 'description': '15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.', 'interventionNames': ['Drug: Cholecalciferol (inactive vitamin D)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin K2 and Cholecalciferol group', 'description': '15 patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D to daily in addition to the standard therapy for 4 months.', 'interventionNames': ['Drug: Cholecalciferol (inactive vitamin D)', 'Drug: Vitamin K2 and Cholecalciferol']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '15 patients will take the standard therapy.'}], 'interventions': [{'name': 'Vitamin K2', 'type': 'DRUG', 'otherNames': ['Group 1'], 'description': 'Patients will take 90 ug of vitamin K2', 'armGroupLabels': ['Vitamin K2 group']}, {'name': 'Cholecalciferol (inactive vitamin D)', 'type': 'DRUG', 'otherNames': ['Group 2'], 'description': 'Patients will take 10 ug of vitamin inactive vitamin D', 'armGroupLabels': ['Cholecalciferol group', 'Vitamin K2 and Cholecalciferol group']}, {'name': 'Vitamin K2 and Cholecalciferol', 'type': 'DRUG', 'otherNames': ['Group 3'], 'description': 'Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D', 'armGroupLabels': ['Vitamin K2 and Cholecalciferol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Radwa Maher El Borolossy, PhD', 'role': 'CONTACT', 'email': 'radwa.maher14@yahoo.com', 'phone': '01227052880'}], 'facility': 'Radwa Maher El Borolossy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of clinical pharmacy', 'investigatorFullName': 'Radwa Maher Abd El Kader El Borolossy', 'investigatorAffiliation': 'Ain Shams University'}}}}