Thoracic DiseasesNCT03034707
Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing
A study testing biotin in people with Thoracic Diseases and Parathyroid Diseases, run by University of Minnesota.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Diseases, Parathyroid Diseases
- What is being tested?
- biotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Thoracic Diseases, Parathyroid Diseases
- Being tested
- biotin
- Keywords
- biotin pharmacokinetic, biotinylated assay, hormone measurement, thyroid, parathyroid, prolactin
- Medical subject headings
- Thoracic Diseases, Parathyroid Diseases, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biotinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Biotin arm | Experimental | biotin 10 mg/day for 7 days Receives: Dietary Supplement: biotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline, at 7 days, at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Boston Medical Center, Children's Mercy Hospital Kansas City
- Responsible party
- Sponsor
- Investigators
- Lynn A Burmeister, MD, Principal investigator, Univ of MinnesotaAngela Radulescu, MD, Study director, Univ of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034707
- Sponsor's protocol ID
- 1602M84022
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2017
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fiume MZ; Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of biotin. Int J Toxicol. 2001;20 Suppl 4:1-12.
PubMed 11800048Meany 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.
PubMed 19717659Kwok 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.
PubMed 22437752Wijeratne 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.
PubMed 23089740Li 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.
PubMed 28973622
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing
- ClinicalTrials.gov ID
- NCT03034707
- Acronym / sponsor ID
- 1602M84022
- Conditions
- Thoracic Diseases, Parathyroid Diseases
- Keywords
- biotin pharmacokinetic, biotinylated assay, hormone measurement, thyroid, parathyroid, prolactin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Boston Medical Center, Children's Mercy Hospital Kansas City
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biotin arm | Experimental | Dietary Supplement: biotinbiotin 10 mg/day for 7 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biotin | Dietary supplement | Biotin arm |
Primary outcome
Hormone measurements TSH, PTH, Total T4, free T4, total T3, free T3, prolactin
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: PubMed 11800048Fiume MZ; Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of biotin. Int J Toxicol. 2001;20 Suppl 4:1-12.
- Background: PubMed 19717659Meany 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.
- Background: PubMed 22437752Kwok 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.
- Background: PubMed 23089740Wijeratne 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.
- Derived from this study: PubMed 28973622Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn A Burmeister, MD principal investigator
Univ of Minnesota
Angela Radulescu, MD study director
Univ of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing biotin in people with Thoracic Diseases and Parathyroid Diseases, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034707, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.