Actively Recruiting
The Acute Interference of Biotin in Blood Analysis
Led by University of Copenhagen · Updated on 2026-05-06
24
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
Sponsors
U
University of Copenhagen
Lead Sponsor
B
Bispebjerg Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is 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. 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
Official Title
The Acute Interference of Biotin in Blood Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 20-70 years of age at time of screening
- Body mass index of 18.6-25 kg/m2
You will not qualify if you...
- Severe liver disease (estimated by FIB4 score > 3.25)
- Type 2 diabetes according to ADA criteria (estimated by HbA1c levels of 248 mmol/mol)
- Significant history of alcoholism or drug/chemical abuse as per investigators judgement
- Kidney disease defined as serum creatinine levels 26 126 bcmol/L for male and 26 111 bcmol/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
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Trial Site Locations
Total: 1 location
1
Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen
Copenhagen, Denmark
Actively Recruiting
Research Team
N
Nicolai J Wewer Albrechtsen
CONTACT
M
Michael M Richter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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