Biotin Urine Collection Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Biotin excretion
研究概览
简要总结
This protocol has been designed for a collection of urine samples from volunteers who will be given high dose biotin supplements over a period of 5 days, in order to provide a research sample bank to examine for biotin excretion rates
详细描述
This is a sample collection study from a minimum of 10 volunteers who will be required to take a Biotin supplement daily for a period of 5 days.
Each volunteer will be asked to read the volunteer information sheet and if they wish to participate in the study, the study admission form will be completed and the volunteer will be asked to sign a consent form.
After informed consent each volunteer will be assigned a unique volunteer number for the duration of the trial to provide anonymity. The volunteer will be provided with a daily diary, urine collection material and a full set of volunteer instructions.
The daily diary will collect the following information;
- Date
- Whether or not supplement was taken and time taken
- sample collection times during the day
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing to take biotin supplements and collect urine samples
- •Has regular menstrual periods
- •SPD employee or partner of SPD employee
排除标准
- •Taking any other supplements or medication (other than contraceptive pill)
- •Taken Antibiotics in the last 4 weeks
- •Diagnosed with metabolic disorder, kidney or liver disease
- •Known Pregnancy or seeking to conceive
- •Breast feeding
- •Undergoing medical investigation for hormone imbalance
- •Condition that contra-indicates pregnancy
- •Condition that contra-indicates use of biotin supplements
研究组 & 干预措施
Biotin
Volunteers to take biotin suppliment
干预措施: Biotin (Dietary Supplement)
结局指标
主要结局
Biotin excretion
时间窗: 2 months
rate of biotin excretion in urine
次要结局
未报告次要终点