Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-31 @ 2:13 PM
Study NCT ID:
NCT01675206
Status:
COMPLETED
Last Update Posted:
2012-08-29
First Post:
2012-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061205', 'term': 'Vascular Calcification'}], 'ancestors': [{'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-25', 'studyFirstSubmitDate': '2012-08-22', 'studyFirstSubmitQcDate': '2012-08-25', 'lastUpdatePostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation', 'timeFrame': '8 weeks', 'description': 'this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP'}], 'secondaryOutcomes': [{'measure': 'Assessment of adverse reactions associated with Vitamin K2 intake', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vascular calcification', 'Hemodialysis', 'Matrix Gla Protein', 'Vitamin K2'], 'conditions': ['Vascular Calcification']}, 'descriptionModule': {'briefSummary': 'This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.', 'detailedDescription': 'During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).\n\nIt is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).\n\nConsequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 year\n* signed informed consent\n* end stage renal disease treated with chronic hemodialysis at least three times a week\n\nExclusion Criteria:\n\n* coumarin treatment\n* known intestinal malabsorption\n* inability to take oral medication\n* medical conditions with a considerable probability for death within 2 months'}, 'identificationModule': {'nctId': 'NCT01675206', 'briefTitle': 'Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Onze Lieve Vrouw Hospital'}, 'officialTitle': 'Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients', 'orgStudyIdInfo': {'id': '2010/066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '360 µg Vit K2', 'description': 'Administration of 360 µg of Vitamin K2 thrice weekly', 'interventionNames': ['Dietary Supplement: Vitamin K2 supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '720 µg Vit K2', 'description': 'Administration of 720 µg of Vitamin K2 thrice weekly', 'interventionNames': ['Dietary Supplement: Vitamin K2 supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1080 µg Vit K2', 'description': 'Administration of 1080 µg of Vitamin K2 thrice weekly', 'interventionNames': ['Dietary Supplement: Vitamin K2 supplementation']}], 'interventions': [{'name': 'Vitamin K2 supplementation', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['1080 µg Vit K2', '360 µg Vit K2', '720 µg Vit K2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rogier Caluwé, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OLV Hospital Aalst Belgium'}, {'name': 'Bruno Van Vlem, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'OLV Hospital Aalst Belgium'}, {'name': 'An Devriese, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'AZ St.-Jan Brugge Belgium'}, {'name': 'Stefaan Vandecasteele, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'AZ St.-Jan Brugge Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rogier Caluwe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Rogier Caluwe', 'investigatorAffiliation': 'Onze Lieve Vrouw Hospital'}}}}