Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
24 participants
INTERVENTIONAL
2026-01-01
2030-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1 (Cohort A): 10 mg of biotin versus placebo
Arm 1: 10 mg biotin → placebo (n = 6)
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 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
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 (Cohort A): 10 mg of biotin versus placebo
Arm 2: placebo → 10 mg biotin (n = 6)
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 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 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.
Arm 3 (Cohort B): 100 mg of biotin versus placebo
Arm 3: 100 mg biotin → placebo (n = 6)
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 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 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.
Arm 4 (Cohort B): 100 mg of biotin versus placebo
Arm 4: placebo → 100 mg biotin (n = 6)
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 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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 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
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
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
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index of 18.6-25 kg/m2
Exclusion Criteria
* 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
20 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bispebjerg Hospital
OTHER
University of Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicolai Jacob Wewer Albrechtsen
Professor, MD, PhD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ABBA
Identifier Type: -
Identifier Source: org_study_id