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Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing

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ClinicalTrials.gov Identifier: NCT03034707
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
Johns Hopkins University
Boston Medical Center
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

January 17, 2017
January 27, 2017
February 12, 2018
April 2016
October 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03034707 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing
Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing
The B vitamin biotin is widely available as an over the counter supplement, often advertised and used to promote health of hair, skin and nails. Commercially available over the counter biotin supplements contain dose ranges up to 10 mg/day (ie 333 times higher than the recommended dietary allowance). The biotin molecule is also sometimes used as part of the lab technology to measure hormone and protein levels in the blood. It is possible that high doses of ingested biotin may interfere with accurate hormone or protein measurement using biotin related in vitro measurement systems. Such interference, if present, could lead to misdiagnosis. The study will analyze laboratory levels obtained with streptavidin-biotin assay systems while ingesting biotin in currently available high dose supplements. The data will be compared to measurements obtained prior to and one week after stopping the biotin supplement.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Thoracic Diseases
  • Parathyroid Diseases
Dietary Supplement: biotin
Experimental: Biotin arm
biotin 10 mg/day for 7 days
Intervention: Dietary Supplement: biotin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
Same as current
December 2018
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy adults

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Known thyroid disease (goiter, abnormal thyroid state),
  3. Thyroid hormone treatment,
  4. Over the counter dietary/ nutritional supplement use currently or within the last 2 weeks (excluding standard multivitamin preparations containing no more than 100% of the daily value for biotin and calcium),
  5. Anticonvulsants,
  6. Night shift work, smokers, adults lacking capacity to consent for themselves
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03034707
1602M84022
No
Not Provided
Plan to Share IPD: No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
  • Johns Hopkins University
  • Boston Medical Center
  • Children's Mercy Hospital Kansas City
Principal Investigator: Lynn A Burmeister, MD Univ of Minnesota
Study Director: Angela Radulescu, MD Univ of Minnesota
University of Minnesota - Clinical and Translational Science Institute
February 2018

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