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Effect of Biotin on Routine Laboratory Values (SafeLab-HAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995277
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf

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

Condition or disease Intervention/treatment Phase
Biotin Ingestion Interference With Routine Analyical Tests Dietary Supplement: Biotin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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).
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests
Actual Study Start Date : January 11, 2019
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Biotin

Arm Intervention/treatment
Healthy cohort - high dose
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
Daily intake of 10 mg or 50 µg per day

Hypothyroid cohort
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
Daily intake of 10 mg or 50 µg per day

Healthy cohort - low dose
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
Daily intake of 10 mg or 50 µg per day




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age above 18 years
  • Apparently healthy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995277


Locations
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Germany
University of Augsburg
Augsburg, Germany, 86156
University Heart Center Hamburg
Hamburg, Germany, 20246
University of Hamburg
Hamburg, Germany, 20246
University of Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Dr. med. Mahir Karakas
Investigators
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Principal Investigator: Mahir Karakas, MD, MBA University Heart Center Hamburg
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Responsible Party: Dr. med. Mahir Karakas, Coordinating Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03995277    
Other Study ID Numbers: SafeLab
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf:
Biotin
Additional relevant MeSH terms:
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Biotin
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs