Effect of Biotin on Routine Laboratory Values

NCT03995277 | Completed Phase 4

• 1 other identifier: SafeLab
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Biotin Ingestion; Interference With Routine Analyical Tests

Keywords

Biotin

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Healthy cohort - high dose

OTHER

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).

Dietary Supplement: Biotin

Hypothyroid cohort

OTHER

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).

Dietary Supplement: Biotin

Healthy cohort - low dose

OTHER

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).

Dietary Supplement: Biotin

Interventions

Biotin DIETARY_SUPPLEMENT

Daily intake of 10 mg or 50 µg per day

Healthy cohort - high dose; Healthy cohort - low dose; Hypothyroid cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• Apparently healthy

You may not qualify if:

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

Sponsors & Collaborators

• Dr. med. Mahir Karakas: lead

Study Sites (4)

University of Augsburg

Augsburg, 86156, Germany

Location

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

University of Hamburg

Hamburg, 20246, Germany

Location

University of Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Interventions

Biotin

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Mahir Karakas, MD, MBA

  University Heart Center Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Model Details: Participants 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).

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 24, 2019
• Study Start: January 11, 2019
• Primary Completion: February 22, 2019
• Study Completion: August 1, 2019
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

DE (4)