Effect of Biotin on Routine Laboratory Values

Phase 4

Completed

• Conditions: Interference With Routine Analyical Tests; Biotin Ingestion

• Registration Number: NCT03995277
• Lead Sponsor: Dr. med. Mahir Karakas

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.

Study Timeline

• Study Start: 2019-01-11
• Primary Completion: 2019-02-22
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-24
• Study Completion: 2019-08-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Age above 18 years
• Apparently healthy

Exclusion Criteria

• Pre-existing condition other than hypothyroidism
• Intake of dietary supplements containing biotin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Variance of routine analyte concentrations	20 days (high-dose groups) and 30 days (low-dose group)	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.

Trial Locations

Locations (4)

University of Augsburg; 🇩🇪 Augsburg, Germany

University Heart Center Hamburg; 🇩🇪 Hamburg, Germany

University of Hamburg; 🇩🇪 Hamburg, Germany

University of Mainz; 🇩🇪 Mainz, Germany