NCT07302880

The Acute Interference of Biotin in Blood Analysis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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. We therefore wish to investigate 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.

Detailed description

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. Therefore, if patients consume biotin supplements before blood tests, biotin may interfere with assays that rely on biotin-based analysis, especially in the first hours after biotin intake. We therefore wish to investigate 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 study will provide data crucial for developing guidelines to manage and interpret test results for patients who have recently taken biotin supplements. The primary aim of this study is to evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption. The investigators hypothesize that biotin intake significantly affects the results of streptavidin-based laboratory assays for up to 5 hours after consumption, leading to inaccurate test results, and that the biotin interference subsides after 24 hours.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2030-03-01
• Completion: 2030-10-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: Denmark