Effect of Biotin on Routine Laboratory Values

Study Overview
=================
Brief Summary
-----------------
Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements.

Detailed Description
-----------------
Study group 1) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in over-the-counter supplements (10 mg/d) in healthy adults and subjects with thyroid hormone supplementation. Therefore, this study was designed to assess the association of short-term biotin ingestion for 10 days with performance of various analytes based on Roche, Abbott and Siemens assays. Study group 2) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in multivitamin supplements (biotin = 50 µg/d) in healthy adults. Therefore, this study was designed to assess the association of short-term biotin ingestion for 20 days with performance of various analytes based on Roche, Abbott and Siemens assays.

Official Title
-----------------
Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests

Conditions
-----------------
Biotin Ingestion, Interference With Routine Analyical Tests

Intervention / Treatment
-----------------
* Dietary Supplement: Biotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years Apparently healthy Exclusion Criteria: Pre-existing condition other than hypothyroidism Intake of dietary supplements containing biotin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Participants take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy cohort - high dose<br>Apparently healthy subjects, who take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20). | Dietary Supplement: Biotin<br>* Daily intake of 10 mg or 50 µg per day<br>|
| Other: Hypothyroid cohort<br>Subjects under thyroid medication, who take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20). | Dietary Supplement: Biotin<br>* Daily intake of 10 mg or 50 µg per day<br>|
| Other: Healthy cohort - low dose<br>Apparently healthy subjects, who take 50 µg/d of biotin at the same time each morning for 20 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), after 20 days of biotin supplementation (day 20), and 10 days after participants stopped taking biotin (day 30). | Dietary Supplement: Biotin<br>* Daily intake of 10 mg or 50 µg per day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variance of routine analyte concentrations | The study aims to assess the performance of specific biotinylated immunoassays after 10 days of ingesting 10 mg/d of biotin (high-dose), or 50 µg/d of biotin (low-dose). Control measurements will be performed at baseline (before biotin intake), and 10 days after last biotin intake. | 20 days (high-dose groups) and 30 days (low-dose group) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biotin