NCT03034707

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

January 17, 2017

Last Update Submit

April 17, 2019

Conditions

Thoracic DiseasesParathyroid Diseases

Keywords

biotin pharmacokineticbiotinylated assayhormone measurementthyroidparathyroidprolactin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Biotin arm

EXPERIMENTAL

biotin 10 mg/day for 7 days

Dietary Supplement: biotin

Interventions

biotinDIETARY_SUPPLEMENT
Biotin arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

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

    PMID: 11800048BACKGROUND

  • 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.

    PMID: 19717659BACKGROUND

  • 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.

    PMID: 22437752BACKGROUND

  • 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.

    PMID: 23089740BACKGROUND

  • 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.

    PMID: 28973622DERIVED

MeSH Terms

Conditions

Thoracic DiseasesParathyroid DiseasesThyroid Diseases

Interventions

Biotin

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Lynn A Burmeister, MD

    Univ of Minnesota

    PRINCIPAL INVESTIGATOR

  • Angela Radulescu, MD

    Univ of Minnesota

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 27, 2017

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 31, 2018

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share