Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 8
- 主要终点
- Variance of routine analyte concentrations
研究概览
简要总结
Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age above 18 years
- •Apparently healthy
排除标准
- •Pre-existing condition other than hypothyroidism
- •Intake of dietary supplements containing biotin
结局指标
主要结局
Variance of routine analyte concentrations
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. med. Mahir Karakas
Coordinating Principal Investigator
Universitätsklinikum Hamburg-Eppendorf