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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 : Completed
First Posted : January 27, 2017
Last Update Posted : April 19, 2019
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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thoracic Diseases Parathyroid Diseases Dietary Supplement: biotin Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Biotin

Arm Intervention/treatment
Experimental: Biotin arm
biotin 10 mg/day for 7 days
Dietary Supplement: biotin



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03034707


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Johns Hopkins University
Boston Medical Center
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Lynn A Burmeister, MD Univ of Minnesota
Study Director: Angela Radulescu, MD Univ of Minnesota

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03034707     History of Changes
Other Study ID Numbers: 1602M84022
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
biotin pharmacokinetic
biotinylated assay
hormone measurement
thyroid
parathyroid
prolactin

Additional relevant MeSH terms:
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Parathyroid Diseases
Thoracic Diseases
Endocrine System Diseases
Respiratory Tract Diseases
Hormones
Biotin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances