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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

Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE January 11, 2019
Actual Primary Completion Date February 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
Variance of routine analyte concentrations [ Time Frame: 20 days ]
The study aims to assess the performance of specific biotinylated immunoassays after 10 days of ingesting 10 mg/d of biotin. Control measurements will be performed at baseline (before biotin intake), and 10 days after last biotin intake.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Biotin on Routine Laboratory Values
Official Title  ICMJE Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Biotin Ingestion
  • Interference With Routine Analyical Tests
Intervention  ICMJE Dietary Supplement: Biotin
Daily intake of 10 mg or 50 µg per day
Study Arms  ICMJE
  • 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).
    Intervention: Dietary Supplement: Biotin
  • 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).
    Intervention: Dietary Supplement: Biotin
  • 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).
    Intervention: Dietary Supplement: Biotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2020)
101
Original Actual Enrollment  ICMJE
 (submitted: June 19, 2019)
51
Actual Study Completion Date  ICMJE August 1, 2019
Actual Primary Completion Date February 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age above 18 years
  • Apparently healthy

Exclusion Criteria:

  • Pre-existing condition other than hypothyroidism
  • Intake of dietary supplements containing biotin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995277
Other Study ID Numbers  ICMJE SafeLab
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Dr. med. Mahir Karakas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mahir Karakas, MD, MBA University Heart Center Hamburg
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP