Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:20 PM
Study NCT ID:
NCT00336232
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2006-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Determinants of Vitamin K Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D014812', 'term': 'Vitamin K'}, {'id': 'D010837', 'term': 'Vitamin K 1'}], 'ancestors': [{'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011809', 'term': 'Quinones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.booth@tufts.edu', 'phone': '617-556-3231', 'title': 'Sarah Booth, PhD', 'organization': 'Tufts University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'duration of study, up to 62 days', 'eventGroups': [{'id': 'EG000', 'title': 'Diet Intervention', 'description': '5 day baseline vitamin K\n\nVitamin K: phylloquinone (vitamin K1) 200 mcg daily\n\n28 day diet low vitamin K\n\nVitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days\n\ntreatment started day 6, completed day 33\n\n28 day diet high vitamin K\n\nVitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month\n\ntreatment started day 34, ended day 61', 'otherNumAtRisk': 42, 'otherNumAffected': 3, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'High blood pressure', 'notes': 'not related to intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'History of blood clotting', 'notes': 'ineligible for study enrollment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial swelling', 'notes': 'not related to intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Phylloquinone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diet Intervention', 'description': '5 day baseline vitamin K\n\nVitamin K: phylloquinone (vitamin K1) 200 mcg daily\n\n28 day diet low vitamin K\n\nVitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days\n\ntreatment started day 6, completed day 33\n\n28 day diet high vitamin K\n\nVitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month\n\ntreatment started day 34, ended day 61'}], 'classes': [{'title': 'low vitamin K', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'high vitamin K', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months', 'description': 'Plasma phylloquinone in response to phylloquinone depletion and repletion', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin K Diet Intervention', 'description': '5 day baseline vitamin K\n\nVitamin K: phylloquinone (vitamin K1) 200 mcg daily\n\n28 day diet low vitamin K\n\nVitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days\n\ntreatment started day 6, completed day 33\n\n28 day diet high vitamin K\n\nVitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month\n\ntreatment started day 34, ended day 61'}], 'periods': [{'title': 'Baseline (200mcg Daily)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}, {'title': 'Low Vitamin K (10mcg Daily)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'High Vitamin K (500mcg Daily)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diet Intervention', 'description': '5 day baseline vitamin K\n\nVitamin K: phylloquinone (vitamin K1) 200 mcg daily\n\n28 day diet low vitamin K\n\nVitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days\n\ntreatment started day 6, completed day 33\n\n28 day diet high vitamin K\n\nVitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month\n\ntreatment started day 34, ended day 61'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Plasma phylloquinone (nmol/L)', 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2006-06-12', 'resultsFirstSubmitDate': '2016-03-07', 'studyFirstSubmitQcDate': '2006-06-12', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-22', 'studyFirstPostDateStruct': {'date': '2006-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Phylloquinone', 'timeFrame': '2 months', 'description': 'Plasma phylloquinone in response to phylloquinone depletion and repletion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin K metabolism', 'Bone health', 'Metabolism'], 'conditions': ['Aging', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '15722567', 'type': 'BACKGROUND', 'citation': 'Harrington DJ, Soper R, Edwards C, Savidge GF, Hodges SJ, Shearer MJ. Determination of the urinary aglycone metabolites of vitamin K by HPLC with redox-mode electrochemical detection. J Lipid Res. 2005 May;46(5):1053-60. doi: 10.1194/jlr.D400033-JLR200. Epub 2005 Feb 1.'}, {'pmid': '14767874', 'type': 'BACKGROUND', 'citation': 'Erkkila AT, Lichtenstein AH, Dolnikowski GG, Grusak MA, Jalbert SM, Aquino KA, Peterson JW, Booth SL. Plasma transport of vitamin K in men using deuterium-labeled collard greens. Metabolism. 2004 Feb;53(2):215-21. doi: 10.1016/j.metabol.2003.08.015.'}, {'pmid': '12888638', 'type': 'BACKGROUND', 'citation': 'Booth SL, Martini L, Peterson JW, Saltzman E, Dallal GE, Wood RJ. Dietary phylloquinone depletion and repletion in older women. J Nutr. 2003 Aug;133(8):2565-9. doi: 10.1093/jn/133.8.2565.'}, {'pmid': '11722960', 'type': 'BACKGROUND', 'citation': "Booth SL, Lichtenstein AH, O'Brien-Morse M, McKeown NM, Wood RJ, Saltzman E, Gundberg CM. Effects of a hydrogenated form of vitamin K on bone formation and resorption. Am J Clin Nutr. 2001 Dec;74(6):783-90. doi: 10.1093/ajcn/74.6.783."}, {'pmid': '25739929', 'type': 'RESULT', 'citation': 'Traber MG, Leonard SW, Bobe G, Fu X, Saltzman E, Grusak MA, Booth SL. alpha-Tocopherol disappearance rates from plasma depend on lipid concentrations: studies using deuterium-labeled collard greens in younger and older adults. Am J Clin Nutr. 2015 Apr;101(4):752-9. doi: 10.3945/ajcn.114.100966. Epub 2015 Mar 4.'}, {'pmid': '22437558', 'type': 'RESULT', 'citation': 'Truong JT, Fu X, Saltzman E, Al Rajabi A, Dallal GE, Gundberg CM, Booth SL. Age group and sex do not influence responses of vitamin K biomarkers to changes in dietary vitamin K. J Nutr. 2012 May;142(5):936-41. doi: 10.3945/jn.111.154807. Epub 2012 Mar 21.'}, {'pmid': '30590596', 'type': 'DERIVED', 'citation': 'Ellis JL, Fu X, Al Rajabi A, Grusak MA, Shearer MJ, Naumova EN, Saltzman E, Barger K, Booth SL. Plasma Response to Deuterium-Labeled Vitamin K Intake Varies by TG Response, but Not Age or Vitamin K Status, in Older and Younger Adults. J Nutr. 2019 Jan 1;149(1):18-25. doi: 10.1093/jn/nxy216.'}], 'seeAlsoLinks': [{'url': 'http://hnrc.tufts.edu', 'label': 'Jean Mayer USDA Human Nutrition Research Center on Aging site'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body stores of vitamin K.', 'detailedDescription': 'Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K supplementation and bone health of women in a narrow age group. This study is the first to assess the role of dietary and other factors that influence the response to vitamin K status and bone turnover to vitamin K depletion and repletion in adults. This study also compares the absorption efficiency and body retention of vitamin K relative to current vitamin K status. Men and women \\[21 younger (18-40y) and 21 older (55+y)\\] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K supplementation period (500 ug/d). Coagulation times will be monitored during the dietary restriction period. Serial measurements of vitamin K status markers and of bone turnover markers will show the response of vitamin K to dietary manipulation for both age groups under identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore, measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin K. The findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin K may have in chronic disease prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* kidney, GI, or liver disease requiring treatment\n* prescribed osteoporosis medications in the previous 3 months\n* use of acid reducers more than twice per week\n* blood clotting disorder and/or abnormal clotting time\n* warfarin or anticoagulant use in the previous 12 months\n* diabetes\n* smoking\n* hormone therapy in the previous 3 months\n* oral contraceptive use in the previous 3 months; pregnancy\n* strict vegetarian diet'}, 'identificationModule': {'nctId': 'NCT00336232', 'briefTitle': 'Determinants of Vitamin K Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Dietary and Non-dietary Components of Vitamin K Metabolism', 'orgStudyIdInfo': {'id': 'R01DK069341', 'link': 'https://reporter.nih.gov/quickSearch/R01DK069341', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet Intervention', 'description': '28 day diet low vitamin K, 28 day diet high vitamin K', 'interventionNames': ['Drug: Vitamin K']}], 'interventions': [{'name': 'Vitamin K', 'type': 'DRUG', 'otherNames': ['phylloquinone'], 'description': 'phylloquinone (vitamin K1) 500 mcg daily in third month', 'armGroupLabels': ['Diet Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sarah L Booth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Sarah Booth', 'investigatorAffiliation': 'Tufts University'}}}}