Testing the Impact of Biotin Supplements (vitamin that helps convert food into energy) on Thyroid Stimulating Hormone Test Results

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"This study hopes to determine if biotin (a vitamin found in dietary supplements) can interfere with a new assay."
Age: 18 years of age and older
Gender:
Any
Healthy Volunteers: Yes
Keywords: biotin, TSH, Thyroid Stimulating Hormone
Type: Observational Study
Target:
500 Participants
Investigator:
Description
Thyroid stimulating hormone (TSH) testing may be affected by biotin. Biotin is a water soluble B-vitamin often recommended as a dietary supplement. It can be found in a variety of other health products found on the market. Certain TSH assays may be affected by biotin and show falsely low results at certain levels of biotin.

This study hopes to determine if biotin can interfere with a new assay. An assay is a blood test that looks for the presence of a substance and the amount of that substance. This assay has recently been approved by the FDA. We will compare the results with results from two different FDA approved assays that have no known interference from biotin.
This study requires

At the time of sample collection: • You will interact with your bedside nurse and a member of the research team. • Blood will be drawn as it would for your routine care. • Samples will come from existing lines already placed for your care, no new lines will be placed. • The sample will be tested on the Beckman DxI Immunoanalyzer as part of routine care. • Remnant or additional sample (about one teaspoon) will be further tested on 2 other instuments; electrochemiluminescent TSH assay (Roche Diagnostics, Indianapolis, IN) and Abbott (Architect i1000) assays. • The sample tested for biotin via mass spectrometry. • All sample collection and testing will be performed at the UC Davis Medical Center Clinical Laboratory. After sample collection, no follow-up is necessary. The total time is 5 minutes and is one time only.

Who can participate

Inclusion

  1. Age ≥ 18 years
  2. Requiring TSH testing

Exclusion

  1. Unable to provide sufficient samples and informed consent
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 5 minutes to collect the sample.
Recruitment period
From May 24, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Stephanie Falwell
Research Topic
Conditions:
  • Lumbar Spinal Stenosis
  • Degenerative Spondylolisthesis