Effect of Biotin on Routine Laboratory Values (SafeLab-HAM)

Dr. med. Mahir Karakas

Status and phase: Completed; Phase 4

Conditions: Biotin Ingestion; Interference With Routine Analyical Tests

Treatments: Dietary Supplement: Biotin

Study type: Interventional

Funder types: Other

Identifiers

NCT03995277

SafeLab

Details and patient eligibility

About

Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age above 18 years
• Apparently healthy

Exclusion criteria

• Pre-existing condition other than hypothyroidism
• Intake of dietary supplements containing biotin

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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101 participants in 3 patient groups

Healthy cohort - high dose

Other group

Description:

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).

Treatment:

Dietary Supplement: Biotin

Hypothyroid cohort

Other group

Description:

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).

Treatment:

Dietary Supplement: Biotin

Healthy cohort - low dose

Other group

Description:

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).

Treatment:

Dietary Supplement: Biotin