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The Acute Interference of Biotin in Blood Analysis

ConditionsBlood SampleInterference With Routine Analyical TestsBiotin Ingestion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorUniversity of Copenhagen

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Male or female between 20-70 years of age at time of screening

Body mass index of 18.6-25 kg/m2

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption

    Other intervention

    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.

  • Arm 1 - 10 mg → Placebo

    Other intervention

    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.

  • Arm 2 - Placebo → 10 mg

    Other intervention

    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.

  • Arm 3 - 100 mg → Placebo

    Other intervention

    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.

  • Arm 4 - Placebo → 100 mg

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Arm 1 (Cohort A): 10 mg of biotin versus placeboExperimental treatment 2 interventions
Group B: Arm 2 (Cohort A): 10 mg of biotin versus placeboExperimental treatment 2 interventions
Group C: Arm 3 (Cohort B): 100 mg of biotin versus placeboExperimental treatment 2 interventions
Group D: Arm 4 (Cohort B): 100 mg of biotin versus placeboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Blood sample on study day at timepoint = 120 minutes.

Secondary outcomes

1

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=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, 180, 240, 300 minutes
2

The effect of 10 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)

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
3

The effect of 10 mg of biotin versus 100 mg biotin on plasma levels of thyroid peroxidase antibody (TPOAb)

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
4

The effect of 100 mg of biotin versus placebo on plasma levels of secondary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Copenhagen

Lead sponsor

Bispebjerg Hospital

Collaborator

Source ClinicalTrials.gov
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