NCT07302880|Recruiting
The Acute Interference of Biotin in Blood Analysis
ABBA
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ABBA
Sponsor study identifier
interventional
24
1 country
1
Study Start
March 17, 2026
Actual (reported)Primary Completion
March 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 11, 2025
Actual (reported)December 24, 2025
Actual (reported)March 17, 2026
Actual (reported)March 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
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).
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)
Blood sample on study day at timepoint = 30, 60, 90, 180, 240, 300 minutes
The effect of 10 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
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)
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
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
Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
Arm 1: 10 mg biotin → placebo (n = 6)
Arm 2: placebo → 10 mg biotin (n = 6)
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.
Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen
Copenhagen, Denmark
First Submitted
December 11, 2025
First Posted
December 24, 2025
Study Start
March 17, 2026
Actual (reported)Primary Completion
Arm 3: 100 mg biotin → placebo (n = 6)
Arm 4: placebo → 100 mg biotin (n = 6)
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.
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March 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2026
Record last verified: 2026-04
We have not decided to share IPD as this also would require approval from the ethical and data approval committee.
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Source: ClinicalTrials.gov.
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