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

Thoracic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034707
• Other study ID #: 1602M84022
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parathyroid Diseases
• Thoracic Diseases

Intervention

Dietary Supplement:
• biotin

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Boston Medical Center, Children's Mercy Hospital Kansas City, Johns Hopkins University

References & Publications (4)

Fiume MZ; Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of biotin. Int J Toxicol. 2001;20 Suppl 4:1-12. Review. — View Citation

Kwok JS, Chan IH, Chan MH. Biotin interference on TSH and free thyroid hormone measurement. Pathology. 2012 Apr;44(3):278-80. doi: 10.1097/PAT.0b013e3283514002. — View Citation

Meany DL, Jan de Beur SM, Bill MJ, Sokoll LJ. A case of renal osteodystrophy with unexpected serum intact parathyroid hormone concentrations. Clin Chem. 2009 Sep;55(9):1737-9. doi: 10.1373/clinchem.2008.121921. — View Citation

Wijeratne NG, Doery JC, Lu ZX. Positive and negative interference in immunoassays following biotin ingestion: a pharmacokinetic study. Pathology. 2012 Dec;44(7):674-5. doi: 10.1097/PAT.0b013e32835a3c17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hormone measurements TSH, PTH, Total T4, free T4, total T3, free T3, prolactin	Hormone measurements using biotinylated assay conducted in certified labratory using the standard lab ranges for each test.	Change from baseline, at 7 days, at 14 days