- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995277
Effect of Biotin on Routine Laboratory Values (SafeLab-HAM)
Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Augsburg, Germany, 86156
- University of Augsburg
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Hamburg, Germany, 20246
- University of Hamburg
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Hamburg, Germany, 20246
- University Heart Center Hamburg
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Mainz, Germany, 55131
- University of Mainz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age above 18 years
- Apparently healthy
Exclusion Criteria:
- Pre-existing condition other than hypothyroidism
- Intake of dietary supplements containing biotin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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).
|
Daily intake of 10 mg or 50 µg per day
|
Other: 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).
|
Daily intake of 10 mg or 50 µg per day
|
Other: 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).
|
Daily intake of 10 mg or 50 µg per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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20 days (high-dose groups) and 30 days (low-dose group)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SafeLab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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