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Completed

NCT Number: NCT03995277

Effect of Biotin on Routine Laboratory Values

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

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Key information

Conditions

Biotin Ingestion Interference With Routine Analyical Tests

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Augsburg, Augsburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 18 years
  • Apparently healthy

Exclusion criteria

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

Treatment and study plan

biotin

Dietary Supplement

Daily intake of 10 mg or 50 µg per day

Primary outcomes

  1. Variance of routine analyte concentrations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. med. Mahir Karakas

Other

Registry information

Official study title

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

Acronym: SafeLab-HAM

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2019
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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