The Acute Interference of Biotin in Blood Analysis

NCT07302880 | Recruiting

• 1 other identifier: ABBA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Sample; Interference With Routine Analyical Tests; Biotin Ingestion

Outcome Measures

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).

  Blood sample on study day at timepoint = 120 minutes.

Secondary Outcomes (6)

• 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

Study Arms (4)

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

EXPERIMENTAL

Arm 1: 10 mg biotin → placebo (n = 6)

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

Arm 2: placebo → 10 mg biotin (n = 6)

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

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

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

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

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

Interventions

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

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 (Cohort A): 10 mg of biotin versus placebo; Arm 2 (Cohort A): 10 mg of biotin versus placebo; Arm 3 (Cohort B): 100 mg of biotin versus placebo; Arm 4 (Cohort B): 100 mg of biotin versus placebo

Arm 1 - 10 mg → Placebo OTHER

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

Arm 2 - Placebo → 10 mg OTHER

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

Arm 3 - 100 mg → Placebo OTHER

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

Arm 4 - Placebo → 100 mg OTHER

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.

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: collaborator
• University of Copenhagen: lead

Study Sites (1)

Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen

Copenhagen, Denmark

RECRUITING

Central Study Contacts

Nicolai J Wewer Albrechtsen

CONTACT

21700880; nicolai.albrechtsen@regionh.dk

Michael M Richter

CONTACT

michael.martin.richter.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Randomized, double-blinded, placebo-controlled, cross-over study.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: March 17, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)