The Acute Interference of Biotin in Blood Analysis

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.

Conditions

• Blood Sample
• Interference With Routine Analyical Tests
• Biotin Ingestion

Interventions

OTHER

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. 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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• Bispebjerg Hospital

  collaborator OTHER

• University of Copenhagen

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-17

Primary Completion

2030-03-01

Completion

2030-10-01

Countries

• Denmark

Study Locations