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RecruitingNot ApplicableNCT07302880

The Acute Interference of Biotin in Blood Analysis

Sponsor

University of Copenhagen

Enrollment

24 participants

Start Date

Mar 17, 2026

Study Type

INTERVENTIONAL

Conditions

Blood SampleInterference With Routine Analyical TestsBiotin Ingestion

Summary

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.

Eligibility

Min Age: 20 YearsMax Age: 70 Years

Inclusion Criteria2

  • Male or female between 20-70 years of age at time of screening
  • Body mass index of 18.6-25 kg/m2

Exclusion Criteria13

  • 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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Interventions

OTHEROverall: 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. The setup is as follows: One 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. One study day with a single oral dose of placebo, followed by a blood sample 24 hours after the study day with placebo. The order of the two trials and the dose of biotin (either 10 mg or 100 mg) will also be randomized at inclusion. During 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.

OTHERArm 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.

OTHERArm 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.

OTHERArm 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.

OTHERArm 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.

Locations(1)

Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen

Copenhagen, Denmark

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NCT07302880