Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Vitastiq device accuracy and performance
研究概览
简要总结
This is a single site evaluation study of Vitastiq device accuracy in healthy men and women in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal devices will be used by volunteers for two months. The Vitastiq device will be evaluated during three site visits: on day 1, 29 ± 4 days and 57 ± 4 days. During site visit days, blood sampling will be collected and analysed and readings using Vitastiq device will be performed. Data will be analysed retrospectively to evaluate Vitastiq performance compared to blood tests results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent form (ICF) is signed by a volunteer
- •Age between 18 and 64 years at the time of the signature of ICF
- •A body mass index (BMI) between 18 and 28 kg/m2
- •Healthy, meaning absence of any chronic or acute medical therapy for a month prior to the inclusion to the study
- •Willing to follow all study procedures, including attending all site visits, and keeping a food diary and diary of activities on a weekly basis
排除标准
- •Intake of any drugs to treat chronic disease within 1 month before the beginning and during the study
- •Intake of any drugs to treat serious acute disease within 1 month before the beginning of the study and within 5 days of each visit
- •Any clinically significant medical history of serious digestive tract, liver, kidney, skin or haematological disease or hormone imbalance
- •Pregnant and breastfeeding women
- •Women who planning pregnancy during the study
- •Inadequate veins (in the opinion of the investigator)
- •Known drug or alcohol abuse
- •Using any form of nicotine or tobacco
- •Mental incapacity that precludes adequate understanding or cooperation
- •Participation in another investigational study or blood donation within 3 months prior to or during this study
结局指标
主要结局
Vitastiq device accuracy and performance
时间窗: 30 minutes
Vitastiq accuracy performance is at least 70% meaning that at least 70% of Vitastiq readings for each mineral and vitamin fall within the range of matching blood test results.
次要结局
- Vitastiq readings method is repeatable(30 minutes)