The Acute Interference of Biotin in Blood Analysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorUniversity of Copenhagen
About this trial
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.
Eligibility criteria
Qualifiers
Male or female between 20-70 years of age at time of screening
Body mass index of 18.6-25 kg/m2
Disqualifiers
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
Trial design
Treatments tested in this trial
- Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption
- Arm 1 - 10 mg → Placebo
- Arm 2 - Placebo → 10 mg
- Arm 3 - 100 mg → Placebo
- Arm 4 - Placebo → 100 mg
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Copenhagen
Lead sponsor
Bispebjerg Hospital
Collaborator
Source ClinicalTrials.gov