NCT Number: NCT07302880
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.
Interested in participating?
Request Info20 year–70 year
All sexes
Interventional
Not applicable
Copenhagen, Denmark
Location status: Recruiting
Michael M Richter
CONTACT
Nicolai J Wewer Albrechtsen
CONTACT
21700880 ext. +45
Nicolai J Wewer Albrechtsen
PRINCIPAL_INVESTIGATOR
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.
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 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: Blood sample on study day at timepoint = 120 minutes.
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t=120 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with placebo).
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 180, 240, 300 minutes
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t=30, 60, 90, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with placebo).
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t= 30, 60, 90, 120, 180, 240 and 300, calculated as the fold change between study day with biotin (10mg biotin) and study day with placebo.)
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus 100 mg biotin on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t=30, 60, 90, 120, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with biotin (10 mg biotin).
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 100 mg of biotin versus placebo on plasma levels of secondary outcomes, including among others insulin, TSH, TnT, C-peptide, ProBNP (defined as the difference in peak concentration levels at t=30, 60, 90, 120, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with placebo).
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus placebo on plasma levels of secondary outcomes, including among others insulin, TSH, TnT, C-peptide, ProBNP (defined as the difference in peak concentration levels at t=30, 60, 90, 120, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (10 mg biotin) and study day with placebo).
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus 100 mg on plasma levels of secondary outcomes, including among others insulin, TSH, TnT, C-peptide, ProBNP (defined as the difference in peak concentration levels at t=30, 60, 90, 120, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with biotin (10 mg).
Contact information is provided by the study sponsor or research team.
University of Copenhagen
Other
Acronym: ABBA
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