Biotin Ingestion, Blood Sample, Interference With Routine Analyical Tests
Conditions
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.
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
OTHEROverall: 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.
OTHERArm 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.
OTHERArm 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.
OTHERArm 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.
OTHERArm 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.
Sponsors
University of Copenhagen
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, double-blinded, placebo-controlled, cross-over study.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) | Blood sample on study day at timepoint = 120 minutes. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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 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.) |
| 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 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). |
| 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 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). |
| 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 | The effect of 10 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 (10 mg biotin) and study day with placebo). |
| The effect of 10 mg of biotin versus 100 mg 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 100 mg 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 biotin (10 mg). |
Countries
Denmark
Contacts
CONTACTNicolai J Wewer Albrechtsen
CONTACTMichael M Richter
Outcome results
None listed