<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03034707</url>
  </required_header>
  <id_info>
    <org_study_id>1602M84022</org_study_id>
    <nct_id>NCT03034707</nct_id>
  </id_info>
  <brief_title>Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing</brief_title>
  <official_title>Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The B vitamin biotin is widely available as an over the counter supplement, often advertised&#xD;
      and used to promote health of hair, skin and nails. Commercially available over the counter&#xD;
      biotin supplements contain dose ranges up to 10 mg/day (ie 333 times higher than the&#xD;
      recommended dietary allowance). The biotin molecule is also sometimes used as part of the lab&#xD;
      technology to measure hormone and protein levels in the blood. It is possible that high doses&#xD;
      of ingested biotin may interfere with accurate hormone or protein measurement using biotin&#xD;
      related in vitro measurement systems. Such interference, if present, could lead to&#xD;
      misdiagnosis. The study will analyze laboratory levels obtained with streptavidin-biotin&#xD;
      assay systems while ingesting biotin in currently available high dose supplements. The data&#xD;
      will be compared to measurements obtained prior to and one week after stopping the biotin&#xD;
      supplement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specimens will be collected by venipuncture at 3 time points, including baseline (time 0),&#xD;
      after one week of biotin supplementation (time 1, day 7), and then one week later (time 2,&#xD;
      day 14). The time 1 specimen will be drawn approximately 2 hours after the last ingested dose&#xD;
      of biotin on day 7. Specimen collection will include three 10 ml red top (no gel) tubes at&#xD;
      each timepoint.&#xD;
&#xD;
      Specimens will be separated for isolation of serum using routine methods of the clinical&#xD;
      chemistry laboratory. Serum will be stored at -80 degrees C until batch measurements as&#xD;
      described Measurements Biotin levels will be measured on each sample. Hormone measurements&#xD;
      will be performed using specific commercially available streptavidin-biotin assays and using&#xD;
      different analyzers as indicated below. Immunoassay methods, not employing&#xD;
      biotin-streptavidin methodology, will be used for negative assay controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hormone measurements TSH, PTH, Total T4, free T4, total T3, free T3, prolactin</measure>
    <time_frame>Change from baseline, at 7 days, at 14 days</time_frame>
    <description>Hormone measurements using biotinylated assay conducted in certified labratory using the standard lab ranges for each test.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Thoracic Diseases</condition>
  <condition>Parathyroid Diseases</condition>
  <arm_group>
    <arm_group_label>Biotin arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>biotin 10 mg/day for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>biotin</intervention_name>
    <arm_group_label>Biotin arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or lactation&#xD;
&#xD;
          2. Known thyroid disease (goiter, abnormal thyroid state),&#xD;
&#xD;
          3. Thyroid hormone treatment,&#xD;
&#xD;
          4. Over the counter dietary/ nutritional supplement use currently or within the last 2&#xD;
             weeks (excluding standard multivitamin preparations containing no more than 100% of&#xD;
             the daily value for biotin and calcium),&#xD;
&#xD;
          5. Anticonvulsants,&#xD;
&#xD;
          6. Night shift work, smokers, adults lacking capacity to consent for themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynn A Burmeister, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univ of Minnesota</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angela Radulescu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Univ of Minnesota</affiliation>
  </overall_official>
  <reference>
    <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>
    <PMID>11800048</PMID>
  </reference>
  <reference>
    <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>
    <PMID>19717659</PMID>
  </reference>
  <reference>
    <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>
    <PMID>22437752</PMID>
  </reference>
  <reference>
    <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>
    <PMID>23089740</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biotin pharmacokinetic</keyword>
  <keyword>biotinylated assay</keyword>
  <keyword>hormone measurement</keyword>
  <keyword>thyroid</keyword>
  <keyword>parathyroid</keyword>
  <keyword>prolactin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Diseases</mesh_term>
    <mesh_term>Parathyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biotin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034707
org study id: 1602M84022
nct id: NCT03034707
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Hormone measurements TSH, PTH, Total T4, free T4, total T3, free T3, prolactin
time frame: Change from baseline, at 7 days, at 14 days
description: Hormone measurements using biotinylated assay conducted in certified labratory using the standard lab ranges for each test.
arm group label: Biotin arm
arm group type: Experimental
description: biotin 10 mg/day for 7 days
intervention type: Dietary Supplement
intervention name: biotin
arm group label: Biotin arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lynn A Burmeister, MD
role: Principal Investigator
affiliation: Univ of Minnesota
last name: Angela Radulescu, MD
role: Study Director
affiliation: Univ of Minnesota
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.
PMID: 11800048
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.
PMID: 19717659
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.
PMID: 22437752
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.
PMID: 23089740
responsible party type: Sponsor
mesh term: Thoracic Diseases
mesh term: Parathyroid Diseases
mesh term: Biotin
sharing ipd: No