Clinical trial NCT03034707: Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing
Official title: Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Diseases
Parathyroid Diseases
Keywords: biotin pharmacokinetic
biotinylated assay
hormone measurement
thyroid
parathyroid
prolactin
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Boston Medical Center
name: Children's Mercy Hospital Kansas City
First posted: 2017-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hormone measurements TSH, PTH, Total T4, free T4, total T3, free T3, prolactin
timeFrame: Change from baseline, at 7 days, at 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Univ of Minnesota
name: Lynn A Burmeister, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univ of Minnesota
name: Angela Radulescu, MD
role: STUDY_DIRECTOR
References:
citation: Fiume MZ; Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of biotin. Int J Toxicol. 2001;20 Suppl 4:1-12.
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. No abstract available.
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. No abstract available.
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. No abstract available.
citation: Li D, Radulescu A, Shrestha RT, Root M, Karger AB, Killeen AA, Hodges JS, Fan SL, Ferguson A, Garg U, Sokoll LJ, Burmeister LA. Association of Biotin Ingestion With Performance of Hormone and Nonhormone Assays in Healthy Adults. JAMA. 2017 Sep 26;318(12):1150-1160. doi: 10.1001/jama.2017.13705.