NCT03995277

Effect of Biotin on Routine Laboratory Values

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Dr. med. Mahir Karakas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Biotin Ingestion
• Interference With Routine Analyical Tests

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Biotin	Daily intake of 10 mg or 50 µg per day

Timeline

• Start date: 2019-01-11
• Primary completion: 2019-02-22
• Completion: 2019-08-01
• First posted: 2019-06-24
• Last updated: 2020-05-22

Locations

4 sites across 1 country: Germany