EICHORCondition: Blood Sample · Interference With Routine Analyical Tests · Biotin Ingestion · Sponsor: University of Copenhagen
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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.
This description comes directly from the study's public registry record.
Nicolai J Wewer Albrechtsen · 21700880 · nicolai.albrechtsen@regionh.dk
Michael M Richter · michael.martin.richter.02@regionh.dk
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Inclusion criteria: * Male or female between 20-70 years of age at time of screening * Body mass index of 18.6-25 kg/m2 Exclusion criteria: * Severe liver disease (estimated by FIB4 score \> 3.25) * Type 2 diabetes according to ADA criteria (estimated by HbA1c levels of ≥ 48 mmol/mol) * Significant history of alcoholism or drug/chemical abuse as per investigators judgement * Kidney disease defined as serum creatinine levels ≥ 126 μmol/L for male and ≥ 111 μmol/L for female or eGFR \< 60 ml/min/1.73 m2 * Cardiac problems (defined as troponin T levels \> 10 ng/L for woman and \>19 ng/L for men) or including any of the following, based on medical history: * Classified as being in New York Heart Association (NYHA) class III or IV * Angina pectoris (chest pain) within the last 6 months * Acute myocardial infarction (heart attack) within last 2 years * Cancer within the past 1 year * Anemia (hemoglobin \<8.3 mmol/L for men and \<7.3 mmol/L for women) * Pregnancy (requires negative pregnancy test) or breast feeding * Smoking * 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
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| Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen | Copenhagen, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07302880