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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03034707
Enrollment
12
Registered
2017-01-27
Start date
2016-04-30
Completion date
2018-12-31
Last updated
2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parathyroid Diseases, Thoracic Diseases

Keywords

biotin pharmacokinetic, biotinylated assay, hormone measurement, thyroid, parathyroid, prolactin

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.

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.

Interventions

DIETARY_SUPPLEMENTbiotin

Sponsors

Johns Hopkins University
CollaboratorOTHER
Boston Medical Center
CollaboratorOTHER
Children's Mercy Hospital Kansas City
CollaboratorOTHER
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hormone measurements TSH, PTH, Total T4, free T4, total T3, free T3, prolactinChange from baseline, at 7 days, at 14 daysHormone measurements using biotinylated assay conducted in certified labratory using the standard lab ranges for each test.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026