The Acute Interference of Biotin in Blood Analysis (ABBA)

University of Copenhagen

Status: Not yet enrolling

Conditions: Biotin Ingestion; Blood Sample; Interference With Routine Analyical Tests

Treatments: Other: Arm 4 - Placebo → 100 mg; Other: Arm 3 - 100 mg → Placebo; Other: Arm 1 - 10 mg → Placebo; Other: Arm 2 - Placebo → 10 mg; Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT07302880

ABBA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups

Arm 1 (Cohort A): 10 mg of biotin versus placebo

Experimental group

Description:

Arm 1: 10 mg biotin → placebo (n = 6)

Treatment:

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

Other: Arm 1 - 10 mg → Placebo

Arm 2 (Cohort A): 10 mg of biotin versus placebo

Experimental group

Description:

Arm 2: placebo → 10 mg biotin (n = 6)

Treatment:

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

Other: Arm 2 - Placebo → 10 mg

Arm 3 (Cohort B): 100 mg of biotin versus placebo

Experimental group

Description:

Arm 3: 100 mg biotin → placebo (n = 6)

Treatment:

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

Other: Arm 3 - 100 mg → Placebo

Arm 4 (Cohort B): 100 mg of biotin versus placebo

Experimental group

Description:

Arm 4: placebo → 100 mg biotin (n = 6)

Treatment:

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

Other: Arm 4 - Placebo → 100 mg