[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bioavailability-of-vitamin-k\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bioavailability-of-vitamin-k":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100596145","bioavailability-of-different-vitamin-k-vitamers-studied-using-13c-labelled-vitamin-k-vitamers-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":22,"type":23},20,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29],"Bioavailability of Vitamin K",[31,32,33],"Bioavailability","vitamin K","13C-labelled vitamin K","NOT_YET_RECRUITING","2025-06-19",{"date":37,"type":38},"2025-06-27","ACTUAL",{"date":40,"type":23},"2025-07-01",{"date":42,"type":23},"2031-06-30",{"name":44,"class":45},"University of Copenhagen","OTHER"]