Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing
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|ClinicalTrials.gov Identifier: NCT03034707|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Diseases Parathyroid Diseases||Dietary Supplement: biotin||Not Applicable|
Specimens will be collected by venipuncture at 3 time points, including baseline (time 0), after one week of biotin supplementation (time 1, day 7), and then one week later (time 2, day 14). The time 1 specimen will be drawn approximately 2 hours after the last ingested dose of biotin on day 7. Specimen collection will include three 10 ml red top (no gel) tubes at each timepoint.
Specimens will be separated for isolation of serum using routine methods of the clinical chemistry laboratory. Serum will be stored at -80 degrees C until batch measurements as described Measurements Biotin levels will be measured on each sample. Hormone measurements will be performed using specific commercially available streptavidin-biotin assays and using different analyzers as indicated below. Immunoassay methods, not employing biotin-streptavidin methodology, will be used for negative assay controls.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Biotin arm
biotin 10 mg/day for 7 days
Dietary Supplement: biotin
- Hormone measurements TSH, PTH, Total T4, free T4, total T3, free T3, prolactin [ Time Frame: Change from baseline, at 7 days, at 14 days ]Hormone measurements using biotinylated assay conducted in certified labratory using the standard lab ranges for each test.
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): NCT03034707
|Principal Investigator:||Lynn A Burmeister, MD||Univ of Minnesota|
|Study Director:||Angela Radulescu, MD||Univ of Minnesota|