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

Not Applicable

Completed

• Conditions: Parathyroid Diseases; Thoracic Diseases
• Interventions: Dietary Supplement: biotin

• Registration Number: NCT03034707
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-10
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-27
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Healthy adults

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biotin arm	biotin	biotin 10 mg/day for 7 days

Primary Outcome Measures

Name	Time	Method
Hormone measurements TSH, PTH, Total T4, free T4, total T3, free T3, prolactin	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.