[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596145":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":58,"collaborators":61,"id":64,"slug":32,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":32,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Copenhagen","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"13C-phylloquinone (13C-PK)","EXPERIMENTAL","The participants will receive one dose of 13C-PK and the levels in blood, urine and feces will be analyzed",[13],"Dietary Supplement: Vitamin K",{"label":15,"type":10,"description":16,"interventionNames":17},"13C-menaquinone-4 (13C-MK-4)","The participants will receive one dose of 13C-MK-4 and the levels in blood, urine and feces will be analyzed",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"13C-menaquinone-7 (13C-MK-7)","The participants will receive one dose of 13C-MK-7 and the levels in blood, urine and feces will be analyzed",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"13C-menaquinone-9 (13C-MK-9)","The participants will receive one dose of 13C-MK-9 and the levels in blood, urine and feces will be analyzed",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Vitamin K","each participant will recive one dose of each of the four vitamin K vitamers but in different orders (4 different orders).",[15,19,23,9],null,[34],{"name":35,"affiliation":5,"role":36},"Susanne G Bügel, Professor","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Susanne Gjedsted Bügel, PhD","CONTACT","35332490","shb@nexs.ku.dk",{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},[45],{"facility":5,"status":32,"city":46,"state":32,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":32,"geoPoint":32,"contacts":50},"Frederiksberg C","1958","Denmark","DK",[51,55,56],{"name":52,"role":40,"phone":53,"phoneExt":32,"email":54},"Marie B Jensen, PhD","26445895","mariebj@nexs.ku.dk",{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},{"name":57,"role":36,"phone":32,"phoneExt":32,"email":32},"Susanne Gjedsted Bügel, Professor",{"type":36,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Susanne Bügel","Professor, Head of Section",[62],{"name":63,"class":6},"Technical University of Denmark","100596145",false,"NCT07041645","Bioavailability of Different Vitamin K Vitamers Studied Using 13C-labelled Vitamin K Vitamers","Bioavailability of Micronutrients With a Special Focus on Vitamin K - Study Part I: K-vitamin","BioMicro","Inclusion Criteria:\n\n* Men and women\n* Between 18 and 65 years old (including both 18 and 65 year olds)\n* Danish-speaking\n* Willingness to consume\u002Fcomply with consumption of study-related intervention products\u002Fdiet\n* Willing to take 10 µg vitamin D3\u002Fday and omit intake of all other (vitamins and mineral) supplements before and during the trial\n* BMI ≤ 30.0 kg\u002Fm2\n\nExclusion Criteria:\n\n* Daily smokers\u002Fusers of all kinds of nicotine-containing products. Occasional smokers\u002Fuser can be included if they are willing to refrain from all kinds of nicotine-containing products during the trial (from screening to end of trial)\n* Blood donation \\\u003C3 months prior to study-related blood sampling\n* Intensive physical training (\\> 10 hours of strenuous physical activity per week)\n* Participation in other clinical studies at the time of the study\n* Pregnant, lactating or planning to become pregnant within the study period\n* Habitual alcohol intake above current recommendation (\\> 10 alcoholic units\u002Fweek)\n* History of cancer within the past five (5) years except basal cell skin cancer and cervix\n* Diagnosed with chronic inflammation disorders\n* Diagnosed with gastrointestinal diseases\n* Diagnosed with bone related diseases\n* Diagnosed with psychiatric disorder including depression that requires medical treatment\n* Medical treatment of diabetes\n* Medical treatment of cardiovascular related disease\n* Surgical change of the gastrointestinal tract (removal of appendix is allowed)\n* Use of prescription medication that can affect their safety or impact on data\n* Inability, physically or mental, to comply with the procedure required by the study protocol and evaluated by the principal investigator (PI), study manager or clinical responsible\n* Medical treatment with anticoagulation medication (warfarin-like types)\n* Allergy or intolerance related to intervention products",true,"ALL","18 Years","65 Years",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80],"NA","Objectives\n\nThe main objectives are:\n\nStudy part I: to investigate the bioavailability of vitamin K vitamers (PK, MK-4, MK-7 and MK-9) in humans using 13C-labelled compounds\n\nHypotheses Study part I: it is hypothesized that there is a difference between the bioavailability of the different vitamers, with MK-9 having the highest bioavailability followed by MK-7, and then PK, while MK-4 will have the lowest bioavailability.\n\nParticipants will:\n\nStudy part I: In the pilot study and study part I, participants will visit NEXS for a test period where a 6.5-hour test day will be carried out and followed up with two short visits on the 2 consecutive days. In the pilot study, there will be one test period with frequent blood sampling (before and after ingestion of a labelled vitamin K vitamer) and urine and faeces sampling. The minimum duration for each participant in the pilot study will be 2.5 weeks. After analyses of the bioavailability of the vitamin K vitamers in the pilot study, results will be used to determine the time points for biological sampling (mainly blood) in study part I. Study part I is a cross-over study with 4 test periods and washout periods in between. The minimum duration for each participant will be 6 weeks.",[83],"Bioavailability of Vitamin K",[85,86,87],"Bioavailability","vitamin K","13C-labelled vitamin K","NOT_YET_RECRUITING","2025-06-19",{"date":91,"type":92},"2025-06-27","ACTUAL",{"date":94,"type":77},"2025-07-01",{"date":96,"type":77},"2031-06-30",{"name":5,"class":6},1]