[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616228":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":35,"centralContacts":52,"locations":62,"responsibleParty":81,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":35,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":35,"overallStatus":65,"whyStopped":35,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Copenhagen","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 (Cohort A): 10 mg of biotin versus placebo","EXPERIMENTAL","Arm 1: 10 mg biotin → placebo (n = 6)",[13,14],"Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption","Other: Arm 1 - 10 mg → Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2 (Cohort A): 10 mg of biotin versus placebo","Arm 2: placebo → 10 mg biotin (n = 6)",[13,19],"Other: Arm 2 - Placebo → 10 mg",{"label":21,"type":10,"description":22,"interventionNames":23},"Arm 3 (Cohort B): 100 mg of biotin versus placebo","Arm 3: 100 mg biotin → placebo (n = 6)",[13,24],"Other: Arm 3 - 100 mg → Placebo",{"label":26,"type":10,"description":27,"interventionNames":28},"Arm 4 (Cohort B): 100 mg of biotin versus placebo","Arm 4: placebo → 100 mg biotin (n = 6)",[13,29],"Other: Arm 4 - Placebo → 100 mg",[31,36,40,44,48],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption","The study will include two experimental days, each lasting 5 hours, as well as two short visits for a blood sample 24 hours after an experimental day.\n\nThe setup is as follows:\n\nOne study day with a single oral dose of biotin (randomized to either 10 mg or 100 mg), followed by a blood sample 24 hours after the study day with biotin.\n\nOne study day with a single oral dose of placebo, followed by a blood sample 24 hours after the study day with placebo.\n\nThe order of the two trials and the dose of biotin (either 10 mg or 100 mg) will also be randomized at inclusion.\n\nDuring the study day, subjects will rest in a supine position and an intravenous catheter is inserted into the left or right antecubital vein for collecting blood samples. Following a blood sample, subjects will receive an oral dose either 10 mg or 100 mg biotin or placebo. In total, blood will be sampled 8 times over a period of 5 hours. After 24 hours, the subject will visit again for a single blood sample.",[9,16,21,26],null,{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Arm 1 - 10 mg → Placebo","Participants receive a 10 mg oral dose of biotin on the first study day and placebo on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later.",[9],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Arm 2 - Placebo → 10 mg","Participants receive placebo on the first study day and a 10 mg oral dose of biotin on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later.",[16],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Arm 3 - 100 mg → Placebo","Participants receive a 100 mg oral dose of biotin on the first study day and placebo on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later.",[21],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":35},"Arm 4 - Placebo → 100 mg","Intervention: Participants receive placebo on the first study day and a 100 mg oral dose of biotin on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later.",[26],[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Nicolai J Wewer Albrechtsen","CONTACT","21700880","45","nicolai.albrechtsen@regionh.dk",{"name":60,"role":55,"phone":35,"phoneExt":57,"email":61},"Michael M Richter","michael.martin.richter.02@regionh.dk",[63],{"facility":64,"status":65,"city":66,"state":35,"zip":35,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen","RECRUITING","Copenhagen","Denmark","DK",{"type":70,"coordinates":71},"Point",[72,73],12.56553,55.67594,{"lat":73,"lon":72},[76,78,79],{"name":54,"role":55,"phone":56,"phoneExt":77,"email":58},"+45",{"name":60,"role":55,"phone":35,"phoneExt":35,"email":61},{"name":54,"role":80,"phone":35,"phoneExt":35,"email":35},"PRINCIPAL_INVESTIGATOR",{"type":80,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Nicolai Jacob Wewer Albrechtsen","Professor, MD, PhD",[85],{"name":86,"class":6},"Bispebjerg Hospital","100616228","the-acute-interference-of-biotin-in-blood-analysis-100616228",false,"NCT07302880","The Acute Interference of Biotin in Blood Analysis","ABBA","Inclusion criteria:\n\n* Male or female between 20-70 years of age at time of screening\n* Body mass index of 18.6-25 kg\u002Fm2\n\nExclusion criteria:\n\n* Severe liver disease (estimated by FIB4 score \\> 3.25)\n* Type 2 diabetes according to ADA criteria (estimated by HbA1c levels of ≥ 48 mmol\u002Fmol)\n* Significant history of alcoholism or drug\u002Fchemical abuse as per investigators judgement\n* Kidney disease defined as serum creatinine levels ≥ 126 μmol\u002FL for male and ≥ 111 μmol\u002FL for female or eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2\n* Cardiac problems (defined as troponin T levels \\> 10 ng\u002FL for woman and \\>19 ng\u002FL for men) or including any of the following, based on medical history:\n\n  * Classified as being in New York Heart Association (NYHA) class III or IV\n  * Angina pectoris (chest pain) within the last 6 months\n  * Acute myocardial infarction (heart attack) within last 2 years\n* Cancer within the past 1 year\n* Anemia (hemoglobin \\\u003C8.3 mmol\u002FL for men and \\\u003C7.3 mmol\u002FL for women)\n* Pregnancy (requires negative pregnancy test) or breast feeding\n* Smoking\n* Any medicine, acute illness (within the last two weeks) or other circumstances that in the opinion of the investigator might endanger the participants' safety or compliance with the protocol",true,"ALL","20 Years","70 Years",{"count":99,"type":100},24,"ESTIMATED","INTERVENTIONAL",[103],"NA","Biotin, also known as vitamin B7, is a water-soluble vitamin. It is essential for several metabolic processes in the body, including glucose, lipid, and protein metabolism, as it acts as a coenzyme in several carboxylation reactions. Biotin, available as an over the counter supplement, is widely used to improve nail and hair growth. The use of biotin supplements can interfere with various laboratory tests, due to the use of the streptavidin-biotin interaction in several immunoassays. The investigators therefore wish to assess the acute impact of biotin supplementation on various laboratory assays, with focus on the immediate post-ingestion effects and the time frame in which biotin interference is most pronounced.",[106,107,108],"Blood Sample","Interference With Routine Analyical Tests","Biotin Ingestion","2026-04-29",{"date":111,"type":112},"2026-05-06","ACTUAL",{"date":114,"type":112},"2026-03-17",{"date":116,"type":100},"2030-10-01",{"name":5,"class":6},1]