Biotin's immediate effect on blood test results
Official title: The Acute Interference of Biotin in Blood Analysis
Run by University of Copenhagen · NCT07302880 · Data updated 2026-11-12
This study will test whether taking a single 10 mg or 100 mg dose of biotin changes common streptavidin-based blood test results in healthy adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 70 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | March 17, 2026 |
| Main results expected | March 1, 2030 |
| Study ends | October 1, 2030 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT07302880 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20–70 with a body mass index between 18.6 and 25 kg/m2 who do not have significant liver, kidney, cardiac disease, diabetes, recent cancer, anemia, or pregnancy are ideal candidates.
✕Probably not a fit
People with chronic illnesses, abnormal BMI outside the required range, ongoing high-dose biotin use, or any of the exclusionary conditions listed are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Healthy adult volunteers receive single oral doses of 10 mg or 100 mg biotin in a crossover sequence with placebo, and blood samples are taken at multiple time points in the hours after ingestion. Laboratory assays that use streptavidin-biotin chemistry are measured to map the magnitude and timing of any interference. The protocol compares results after biotin versus placebo to determine how long post-ingestion assays remain affected. Investigators hypothesize measurable interference within the first 5 hours that returns to baseline by 24 hours.
Why it matters
Potential benefit: If successful, the results could give clear guidance on how soon after taking biotin clinicians should avoid or interpret streptavidin-based blood tests to prevent misdiagnosis.
How similar studies have gone: Biotin interference with streptavidin-based immunoassays is well documented in the literature, but controlled acute time-course data at defined 10 mg and 100 mg doses are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Nicolai J Wewer Albrechtsen
- Email: nicolai.albrechtsen@regionh.dk
- Phone: 21700880
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.