Effect of Biotin on Routine Laboratory Values

Biotin Ingestion Clinical Trial

— SafeLab-HAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995277
• Other study ID #: SafeLab
• Status: Completed
• Phase: Phase 4
• Start date: January 11, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 1, 2019
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years

• Apparently healthy

Exclusion Criteria:

• Pre-existing condition other than hypothyroidism

• Intake of dietary supplements containing biotin

Related Conditions & MeSH terms

• Biotin Ingestion
• Interference With Routine Analyical Tests

Intervention

Dietary Supplement:
• Biotin
Daily intake of 10 mg or 50 µg per day

Locations

Country	Name	City	State
Germany	University of Augsburg	Augsburg
Germany	University Heart Center Hamburg	Hamburg
Germany	University of Hamburg	Hamburg
Germany	University of Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Dr. med. Mahir Karakas

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)