Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 2:08 AM
Study NCT ID:
NCT01002157
Status:
UNKNOWN
Last Update Posted:
2018-09-13
First Post:
2009-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062629', 'term': 'menaquinone 7'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2009-10-26', 'studyFirstSubmitQcDate': '2009-10-26', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary Artery Calcification-score progression', 'timeFrame': '12 and 24 months'}], 'secondaryOutcomes': [{'measure': 'Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity', 'timeFrame': '0, 12 and 24 months'}, {'measure': 'Carotid Intima Media Thickness', 'timeFrame': '0, 12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Calcification', 'Vitamin K', 'Trial', 'Treatment'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Both Coronary Artery Calcification (CAC)and its annual progression are a strong predictors of cardiovascular events. The development of arterial calcification results from imbalance between calcification promoting and inhibiting factors. An important inhibitor of calcification is Matrix Gla Protein (MGP): a protein present in the vascular wall where it is synthesized by Vascular Smooth Muscle Cells (VSMC). MGP requires Vitamin K-mediated carboxylation to function properly. Deficiency of Vitamin K has been demonstrated to cause arterial calcification and a diet containing large amounts of Vitamin K2 was associated with lower CAC and cardiovascular risk. In animal studies, active supplementation of Vitamin K2 caused regression of existing arterial calcification. Therefore, the aim of this randomized, double-blind, placebo-controlled clinical trial is to investigate whether daily supplementation of Vitamin K2 (Menaquinone-7) to patients with established CAC will lead to a decreased progression-rate of CAC after 24 months of follow-up in comparison to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality\n* Baseline Agatston calciumscore 100 - 400\n\nExclusion Criteria:\n\n* Baseline-scan of insufficient quality\n* Heart rate greater than 70 beats per minute during first scan.(despite adequate treatment with metoprolol)\n* Chronic or paroxysmal Atrial Fibrillation\n* Presence or scheduled coronary revascularization procedure\n* History of myocardial infarction or stroke.\n* Presence of Diabetes Mellitus.\n* Known kidney disease or a Glomerular Filtration Rate (GFR)MDRD \\< 60 ml/min/1.73m2\n* Malignant disease (exception: treated basal-cell or squamous cell carcinoma).\n* Use of Vitamin K antagonists.\n* A life-expectancy \\< 2 years\n* Pregnancy or wish to become pregnant in the near future.'}, 'identificationModule': {'nctId': 'NCT01002157', 'acronym': 'VitaK-CAC', 'briefTitle': 'The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification', 'orgStudyIdInfo': {'id': 'MEC09-2-075'}, 'secondaryIdInfos': [{'id': 'NL27372.068.09'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin K2 supplementation', 'interventionNames': ['Dietary Supplement: Menaquinone-7 (Vitamin K2)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo control', 'interventionNames': ['Other: Placebo capsules']}], 'interventions': [{'name': 'Menaquinone-7 (Vitamin K2)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Menaquinone-7 (Vitamin K2)', 'armGroupLabels': ['Vitamin K2 supplementation']}, {'name': 'Placebo capsules', 'type': 'OTHER', 'description': 'Capsules containing no Menaquinone-7', 'armGroupLabels': ['Placebo control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Abraham Kroon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}, {'name': 'Peter de Leeuw, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'VitaK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}