Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT01922804
Status:
UNKNOWN
Last Update Posted:
2016-10-28
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D024482', 'term': 'Vitamin K 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2013-08-13', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'p-undercarboxylated osteocalcin', 'timeFrame': 'Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial.'}], 'secondaryOutcomes': [{'measure': 'Change in bone mineral density', 'timeFrame': 'Assessed after 3, 6, 12, 24 and 36 months', 'description': 'Change in bone mineral density measured by DXA scans (Dual energy x-ray absorptiometry)'}, {'measure': 'Change in arterial stiffness, pulse wave velocity', 'timeFrame': 'Measured at baseline and after 6 months', 'description': 'Change in pulse wave velocity after 6 months.'}, {'measure': 'Change in insulin sensitivity', 'timeFrame': 'Measured at baseline and after 1 and 12 months.', 'description': 'Change in insulin sensitivity. Determined by HOMA-test (homeostasis model assessment), using fasting plasma glucose and insulin.'}, {'measure': 'Change in bone turnover markers', 'timeFrame': 'Measured at baseline, after 1, 3, 6, 12, 24 and 36 months'}, {'measure': 'Change in bone structure', 'timeFrame': 'baseline and month 12', 'description': 'HRpQCT scans'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolic Bone Disorder']}, 'referencesModule': {'references': [{'pmid': '33030563', 'type': 'DERIVED', 'citation': 'Ronn SH, Harslof T, Oei L, Pedersen SB, Langdahl BL. The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial. Osteoporos Int. 2021 Jan;32(1):185-191. doi: 10.1007/s00198-020-05638-z. Epub 2020 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis.\n\nOsteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.\n\nOur hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.', 'detailedDescription': 'Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.\n\nOur hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postmenopausal women\n* 60-80 years\n* osteopenia\n\nExclusion Criteria:\n\n* Calcium metabolic, thyroid, liver or kidney disease\n* Diabetes\n* Obesity\n* Myocardial infarction or other arteriosclerotic events\n* Angina pectoris\n* Vitamin D \\< 50 nmol/L\n* Treatment with vitamin K antagonists\n* Use of vitamin K supplements in the last month or for more than 3 months at any time\n* Treatment with drugs with known effects on bone metabolism or glucose metabolism.\n* Smoking in the last 12 months\n* Drug or alcohol abuse\n* Allergy to calcium, vitamin D or vitamin K.'}, 'identificationModule': {'nctId': 'NCT01922804', 'acronym': 'K2vita', 'briefTitle': 'Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification', 'orgStudyIdInfo': {'id': 'K2vita'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'K2 vitamin', 'description': 'K2 vitamin 375 microgram a day for 3 years', 'interventionNames': ['Dietary Supplement: K2 vitamin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '1 tablet a day for 3 years', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'K2 vitamin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'K2 vitamin tablet', 'armGroupLabels': ['K2 vitamin']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo tablets', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Endocrinology and Internal Medicine THG', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Sofie Rønn, cand.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Axellus', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}