Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT00642551
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beneficial Effects of Long Term Menaquinone-7
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062629', 'term': 'menaquinone 7'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-11', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound', 'timeFrame': 'three years'}], 'secondaryOutcomes': [{'measure': 'The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)', 'timeFrame': 'three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin K2', 'menaquinone-7', 'bone health', 'vascular health'], 'conditions': ['Bone Loss', 'Arteriosclerosis']}, 'referencesModule': {'references': [{'pmid': '22136751', 'type': 'DERIVED', 'citation': 'Knapen MH, Schurgers LJ, Shearer MJ, Newman P, Theuwissen E, Vermeer C. Association of vitamin K status with adiponectin and body composition in healthy subjects: uncarboxylated osteocalcin is not associated with fat mass and body weight. Br J Nutr. 2012 Sep 28;108(6):1017-24. doi: 10.1017/S000711451100626X. Epub 2011 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy postmenopausal women between 55 and 65 years old\n* Subjects of normal body weight and height according to BMI \\< 30\n* Subjects of Caucasian race\n* Subject has given written consent to take part in the study\n\nExclusion Criteria:\n\n* Subjects with (a history of) metabolic or gastrointestinal disease\n* Subjects presenting chronic degenerative and/or inflammatory disease\n* Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters\n* Subjects receiving corticoϊd treatment\n* Subjects using oral anticoagulants\n* Subject using bisphosphonates\n* Subjects using hormone replacement therapy\n* Subjects undergoing ovariectomy and/or hysterectomy\n* Subject with (a history of) soy allergy\n* Subjects using vitamin K containing multivitamins or vitamin K supplements\n* Subjects who have participated in a clinical study more recently than one month before the current study\n* Subjects who are found to be osteoporotic at baseline (T-score \\< -2.5)'}, 'identificationModule': {'nctId': 'NCT00642551', 'briefTitle': 'Beneficial Effects of Long Term Menaquinone-7', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Clinical Trial on Beneficial Effects of Long Term Menaquinone-7 (Vitamin K2) Intake by Postmenopausal Women', 'orgStudyIdInfo': {'id': '07-3-074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MK-7', 'description': '1 capsule per day existing of 180 µg menaquinone-7', 'interventionNames': ['Dietary Supplement: menaquinone-7']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 placebo capsule per day for three years', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'menaquinone-7', 'type': 'DIETARY_SUPPLEMENT', 'description': '180 µg menaquinone-7 daily for three years', 'armGroupLabels': ['MK-7']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 placebo capsule daily for three years', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 MD', 'city': 'Maastricht', 'state': 'PO Box 616', 'country': 'Netherlands', 'facility': 'VitaK BV / Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Cees Vermeer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}