Biotin IngestionPhase 4SafeLab-HAMNCT03995277
Effect of Biotin on Routine Laboratory Values
A Phase 4 study testing Biotin in people with Biotin Ingestion and Interference With Routine Analyical Tests, run by Dr. med. Mahir Karakas at 4 sites in Germany.
Trial summary
Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biotin Ingestion, Interference With Routine Analyical Tests
- What is being tested?
- Biotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 4 sitesGermany
- Study dates
- 11 Jan 2019to 1 Aug 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18 years
- Apparently healthy
Who cannot join
- Pre-existing condition other than hypothyroidism
- Intake of dietary supplements containing biotin
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
University of Augsburg
Augsburg, 86156
University Heart Center Hamburg
Hamburg, 20246
University of Hamburg
Hamburg, 20246
University of Mainz
Mainz, 55131
About this study
Official title: Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests
Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements.
Read the detailed description
Study group 1) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in over-the-counter supplements (10 mg/d) in healthy adults and subjects with thyroid hormone supplementation. Therefore, this study was designed to assess the association of short-term biotin ingestion for 10 days with performance of various analytes based on Roche, Abbott and Siemens assays.
Study group 2) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in multivitamin supplements (biotin = 50 µg/d) in healthy adults. Therefore, this study was designed to assess the association of short-term biotin ingestion for 20 days with performance of various analytes based on Roche, Abbott and Siemens assays.
- Being tested
- Biotin
- Keywords
- Biotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiotinDietary supplement
Daily intake of 10 mg or 50 µg per day
| Study group | Role | What they receive |
|---|---|---|
| Healthy cohort - high dose | Other | Apparently healthy subjects, who take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20). Receives: Dietary Supplement: Biotin |
| Hypothyroid cohort | Other | Subjects under thyroid medication, who take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20). Receives: Dietary Supplement: Biotin |
| Healthy cohort - low dose | Other | Apparently healthy subjects, who take 50 µg/d of biotin at the same time each morning for 20 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), after 20 days of biotin supplementation (day 20), and 10 days after participants stopped taking biotin (day 30). Receives: Dietary Supplement: Biotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variance of routine analyte concentrations
The study aims to assess the performance of specific biotinylated immunoassays after 10 days of ingesting 10 mg/d of biotin (high-dose), or 50 µg/d of biotin (low-dose). Control measurements will be performed at baseline (before biotin intake), and 10 days after last biotin intake.
Measured: 20 days (high-dose groups) and 30 days (low-dose group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start11 Jan 2019
- Primary completion22 Feb 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biotin IngestionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. med. Mahir Karakas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Mahir Karakas, MD, MBA, Principal investigator, University Heart Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995277
- Sponsor's protocol ID
- SafeLab
- Acronym
- SafeLab-HAM
- Status last verified
- May 2020
- First submitted
- 17 Jun 2019
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests
- ClinicalTrials.gov ID
- NCT03995277
- Acronym / sponsor ID
- SafeLab-HAM / SafeLab
- Keywords
- Biotin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Dr. med. Mahir KarakasUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 24 Jun 2019 (actual)
- 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.
Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements.
Detailed description
Study group 1) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in over-the-counter supplements (10 mg/d) in healthy adults and subjects with thyroid hormone supplementation. Therefore, this study was designed to assess the association of short-term biotin ingestion for 10 days with performance of various analytes based on Roche, Abbott and Siemens assays.
Study group 2) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in multivitamin supplements (biotin = 50 µg/d) in healthy adults. Therefore, this study was designed to assess the association of short-term biotin ingestion for 20 days with performance of various analytes based on Roche, Abbott and Siemens assays.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20).
| Arm | Type | Receives |
|---|---|---|
| Healthy cohort - high dose | Other | Dietary Supplement: BiotinApparently healthy subjects, who take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20). |
| Hypothyroid cohort | Other | Dietary Supplement: BiotinSubjects under thyroid medication, who take 10 mg/d of biotin at the same time each morning for 10 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), and 10 days after participants stopped taking biotin (day 20). |
| Healthy cohort - low dose | Other | Dietary Supplement: BiotinApparently healthy subjects, who take 50 µg/d of biotin at the same time each morning for 20 days. Blood draw for biobanking will be collected at baseline prior to starting biotin (day 1), after 10 days of biotin supplementation (day 10), after 20 days of biotin supplementation (day 20), and 10 days after participants stopped taking biotin (day 30). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above 18 years
- Apparently healthy
Key exclusion criteria (2 listed)
- Pre-existing condition other than hypothyroidism
- Intake of dietary supplements containing biotin
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 |
|---|---|---|
| BiotinDaily intake of 10 mg or 50 µg per day | Dietary supplement | Healthy cohort - high dose, Healthy cohort - low dose, Hypothyroid cohort |
Primary outcome
Variance of routine analyte concentrations
Time frame: 20 days (high-dose groups) and 30 days (low-dose group)
The study aims to assess the performance of specific biotinylated immunoassays after 10 days of ingesting 10 mg/d of biotin (high-dose), or 50 µg/d of biotin (low-dose). Control measurements will be performed at baseline (before biotin intake), and 10 days after last biotin intake.
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 22 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Biotin Ingestion
Recruiting
The Acute Interference of Biotin in Blood Analysis
Blood Sample, Interference With Routine Analyical Tests
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.
Mahir Karakas, MD, MBA principal investigator
University Heart Center Hamburg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biotin in people with Biotin Ingestion and Interference With Routine Analyical Tests, run by Dr. med. Mahir Karakas at 4 sites in Germany.
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 2 inclusion and 2 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Variance of routine analyte concentrations (time frame: 20 days (high-dose groups) and 30 days (low-dose group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2020.