Effect of Biotin on Routine Laboratory Values

Phase 4

Completed

• Conditions: Interference With Routine Analyical Tests; Biotin Ingestion
• Interventions: Dietary Supplement: Biotin

• 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

Arm && Interventions

Group	Intervention	Description
Healthy cohort - low dose	Biotin	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).
Healthy cohort - high dose	Biotin	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).
Hypothyroid cohort	Biotin	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).

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 Heart Center Hamburg; 🇩🇪 Hamburg, Germany

University of Augsburg; 🇩🇪 Augsburg, Germany

University of Hamburg; 🇩🇪 Hamburg, Germany

University of Mainz; 🇩🇪 Mainz, Germany