The Acute Interference of Biotin in Blood Analysis

Overview

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.

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.

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.

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
• 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.

Primary outcome measures

• The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) [Time frame: Blood sample on study day at timepoint = 120 minutes.]

Secondary outcome measures (6)

• The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) [Time frame: 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) [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) [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 [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 [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 [Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes]

Eligibility criteria

Inclusion criteria

• Male or female between 20-70 years of age at time of screening
• Body mass index of 18.6-25 kg/m2

Exclusion criteria

• 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
• Cardiac problems (defined as troponin T levels > 10 ng/L for woman and >19 ng/L for men) or including any of the following, based on medical history:

• Classified as being in New York Heart Association (NYHA) class III or IV
• Angina pectoris (chest pain) within the last 6 months
• Acute myocardial infarction (heart attack) within last 2 years
• Cancer within the past 1 year
• Anemia (hemoglobin <8.3 mmol/L for men and <7.3 mmol/L for women)
• Pregnancy (requires negative pregnancy test) or breast feeding
• Smoking
• Any medicine, acute illness (within the last two weeks) or other circumstances that in the opinion of the investigator might endanger the participants' safety or compliance with the protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Basic science

Study locations

Denmark · 1 center

• Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen — Copenhagen

Identifiers

NCT: NCT07302880 · ABBA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗