Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT00150969
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vitamin K Supplementation in Post-Menopausal Osteopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'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': 'D010837', 'term': 'Vitamin K 1'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jscher@uhnresearch.ca', 'phone': '416-340-4841', 'title': 'Dr. Angela M Cheung', 'organization': 'University Health Network'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Originally designed as a 2-year study with BMD as primary outcome. Thus, the number of women followed to 3 and 4 years was small, and the study was not powered to examine fracture outcomes.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for the entire study period of 48 months', 'eventGroups': [{'id': 'EG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1', 'otherNumAtRisk': 217, 'otherNumAffected': 11, 'seriousNumAtRisk': 217, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k', 'otherNumAtRisk': 223, 'otherNumAffected': 10, 'seriousNumAtRisk': 223, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'nausea and vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}], 'seriousEvents': [{'term': 'hospitalization', 'notes': 'these include pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgeries.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Cancer', 'notes': 'cancers include uterine (2), vaginal(1), esophagus(1), thyroid(3), breast(7), lung (1)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Death', 'notes': 'Causes of death include motor vehicle accident (1), arrhthmogenic right ventricular cardiomyopathy(1) cancer(3),', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.28', 'spread': '3.5', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '0.54'}, {'value': '-1.22', 'spread': '3.0', 'groupId': 'OG001', 'lowerLimit': '-0.67', 'upperLimit': '0.54'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.47', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.49', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-2.55', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.'}, {'type': 'SECONDARY', 'title': 'Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '24', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-24 months', 'description': 'measured by osteocalcin on elecsys platform', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-24 months', 'description': 'measured by CTX Elisa assay on elecsys platform', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.4', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 months', 'description': 'measured by osteocalcin hydroxyapatite binding assay', 'unitOfMeasure': 'percentage of undercarboxylated OC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.39', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 48 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.69', 'spread': '2.8', 'groupId': 'OG000', 'lowerLimit': '-0.37', 'upperLimit': '0.75'}, {'value': '-0.88', 'spread': '3.2', 'groupId': 'OG001', 'lowerLimit': '-0.37', 'upperLimit': '0.75'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 48 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.05', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '-2.71', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 48 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.35', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-5.23', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 48 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer', 'unitOfMeasure': 'percentage change in BMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 months', 'description': 'These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Number of New Cancers by Treatment Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Number of New Clinical Fractures by Treatment Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1 daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 months', 'description': 'these included fragility fractures', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}], 'periods': [{'title': '24 Month Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '202'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': '24-48 Month Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '100'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '91'}]}]}], 'recruitmentDetails': 'recruitment from January 2002 to September 2006 through health fairs, community posters and advertisements.', 'preAssignmentDetails': '453 participants signed consent. 13 were not included in analysis(10 screen failure,3 drop out at baseline)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phyloquinone', 'description': '5 mg Vitamin K1'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'dummy pill identicle to vitamin k'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'groupId': 'BG000', 'lowerLimit': '40.1', 'upperLimit': '80.5'}, {'value': '59.2', 'groupId': 'BG001', 'lowerLimit': '46.1', 'upperLimit': '82.3'}, {'value': '59.0', 'groupId': 'BG002', 'lowerLimit': '40.1', 'upperLimit': '82.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All Participants were community dwelling post-menopausal women', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2005-09-06', 'resultsFirstSubmitDate': '2012-01-10', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-02-23', 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.', 'timeFrame': '0 to 24 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.', 'timeFrame': '0 to 24 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.', 'timeFrame': '0 to 24 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.', 'timeFrame': '0 to 24 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer'}, {'measure': 'Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker', 'timeFrame': '0-24 months', 'description': 'measured by osteocalcin on elecsys platform'}, {'measure': 'Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)', 'timeFrame': '0-24 months', 'description': 'measured by CTX Elisa assay on elecsys platform'}, {'measure': 'Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin', 'timeFrame': '0 to 24 months', 'description': 'measured by osteocalcin hydroxyapatite binding assay'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.', 'timeFrame': '0 to 48 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.', 'timeFrame': '0 to 48 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.', 'timeFrame': '0 to 48 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.', 'timeFrame': '0 to 48 months', 'description': 'BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer'}, {'measure': 'Difference in Serious Adverse Events', 'timeFrame': 'up to 48 months', 'description': 'These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.'}, {'measure': 'Difference in Number of New Cancers by Treatment Arm.', 'timeFrame': 'up to 48 months'}, {'measure': 'Difference in Number of New Clinical Fractures by Treatment Arm.', 'timeFrame': 'up to 48 months', 'description': 'these included fragility fractures'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin K', 'bone mineral density', 'post-menopausal women', 'randomized double blind placebo controlled trial', 'osteoporosis', "women's health"], 'conditions': ['Post-Menopausal Osteoporosis', 'Post-Menopausal Osteopenia']}, 'referencesModule': {'references': [{'pmid': '18922041', 'type': 'RESULT', 'citation': 'Cheung AM, Tile L, Lee Y, Tomlinson G, Hawker G, Scher J, Hu H, Vieth R, Thompson L, Jamal S, Josse R. Vitamin K supplementation in postmenopausal women with osteopenia (ECKO trial): a randomized controlled trial. PLoS Med. 2008 Oct 14;5(10):e196. doi: 10.1371/journal.pmed.0050196.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.', 'detailedDescription': 'Osteoporosis is major cause of morbidity and mortality in Canadian postmenopausal women. It is a systemic disease characterized by low bone mass and deterioration of bone microarchitecture, resulting in bone fragility and an increased risk of fractures. One in six women over the age of 50 have osteoporosis. The lifetime risk of an osteoporotic fracture for an average 50 year-old Canadian woman is \\>40%. The annual health care costs for osteoporotic fractures in Canada have been estimated to exceed $1.3 billion.\n\nRecent data suggest that vitamin K supplements may decrease bone loss and prevent fractures. Vitamin K is a co-factor of gamma-glutamyl carboxylase, an enzyme that catalyzes the gamma-carboxylation of glutamic acid residues in bone matrix proteins such as osteocalcin. Vitamin K has been reported to enhance bone formation in both in vitro studies and in vivo studies in animals. Vitamin K levels are low in individuals with osteoporosis and in patients with osteoporotic fractures. The few studies examining vitamin K supplementation in humans have showed promising results with no significant side effects, but these studies had significant methodological shortcomings such as inadequate sample size and lack of randomization.\n\nThe primary objective of our study is to examine whether vitamin K supplementation will increase bone mineral density in postmenopausal women with osteopenia. Our secondary objectives are to examine the possible adverse effects from long-term vitamin K supplementation, to investigate whether vitamin K will decrease risk of fractures and to determine if vitamin K affects quality of life. Our hypotheses are that vitamin K increases bone mineral density in postmenopausal women, and that there are no significant adverse effects from vitamin K supplementation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPostmenopausal: One year since the natural cessation of menses, or Hysterectomy with either postmenopausal status confirmed by FSH lab values, or age 55 and above AND 2. Osteopenic: T-score at baseline has to be between (and including) -1.0 and\n\n-2.0 in the lumbar spine (L1-L4), total hip or femoral neck, and the lowest reading of the above three measurements must be between -1.0 and -2.0\n\nExclusion Criteria:\n\n1. Women ever having had a fragility fracture after age 40;\n2. Women currently on anticoagulants, previously on anticoagulants in the past 3 months, or expected to be on anticoagulants in the near future;\n3. Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during the past 3 months;\n4. Women who have ever been on a bisphosphonate for more than 6 months;\n5. Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidism or other metabolic bone diseases;\n6. Women with decompensated diseases of the liver, kidney, pancreas, lung, or heart;\n7. Women with a history of active cancer in the past 5 years;\n8. Women taking mega-doses of vitamin A (more than 10,000 iu per day) or E (more than 400 iu per day);\n9. Women involved in other clinical trials;\n10. Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study."}, 'identificationModule': {'nctId': 'NCT00150969', 'briefTitle': 'Vitamin K Supplementation in Post-Menopausal Osteopenia', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia (ECKO Trial)', 'orgStudyIdInfo': {'id': '01-0169'}, 'secondaryIdInfos': [{'id': '50422', 'type': 'OTHER_GRANT', 'domain': 'Canadian Institute for Health Research (CIHR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'phyloquinone', 'description': '5 mg Vitamin K1', 'interventionNames': ['Dietary Supplement: vitamin K1 (phylloquinone)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'vitamin K1 (phylloquinone)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['phyloquinone']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 pill daily', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 2T2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital Health Centre", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network, Osteoporosis Department', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 1B2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Sunnybrook & Women's College Health Sciences Centre", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 3E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Angela M Cheung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}