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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thoracic Diseases Endocrine System Diseases Parathyroid Diseases Respiratory Tract Diseases Thyroid Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adults

Exclusion criteria

Pregnancy or lactation
Known thyroid disease (goiter, abnormal thyroid state),
Thyroid hormone treatment,
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),
Anticonvulsants,
Night shift work, smokers, adults lacking capacity to consent for themselves

Treatment and study plan

biotin

Dietary Supplement

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

Boston Medical Center
Children's Mercy Hospital Kansas City
Johns Hopkins University

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2018
First posted: Jan 27, 2017
Registry last updated: Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed