The Acute Interference of Biotin in Blood Analysis (NCT07302880) | Clinical Trial Compass
RecruitingNot Applicable
The Acute Interference of Biotin in Blood Analysis
Denmark24 participantsStarted 2026-03-17
Plain-language 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.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
Timeframe: Blood sample on study day at timepoint = 120 minutes.