Behaviour Intervention to Decrease Melamine Exposure (Bidme)
研究概览
详细说明
Study subjects:
Two tiers:
- Recruit 88 student volunteers from two university buildings and collect their morning one-spot urine specimens for 3 consecutive days (44 students in each building (Building A and Building B)
- Select appropriate study subjects with high excretion of urinary melamine and with consuming melamine tableware containing hot water or hot soup by questionnaire in the past 3 days for intervention.
Study protocol:
This is a cluster randomized crossover intervention. We will conduct this study for 9 days and each experimental step lasts for 3 days. We randomly assign one building with 8 appropriate study subjects to a serial of control-intervention-intervention steps and another building with also 8 appropriate study subjects to a serial of control-control-intervention steps. Intervention step means study subjects will carry one big bag containing two stainless containers, one stainless spoon, and one stainless chopstick and use them for each meal during the trial (Some subjects will need to take pictures randomly and email back before the meal). Control means study subjects will carry one big bag without those stainless container, spoon, and chopstick and only use the containers provided by vendors for each meal during the trial (Some subjects will need to take pictures randomly and email back before the meal to check their adherence). Collect 24-hr urine samples for 9 days for melamine levels.
Inclusion criteria: 20-30 healthy students Exclusion criteria: Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, including urinary tract infection, or renal stones; Family history of renal stones; Body weight less than 50 kg.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Kaohsiung、台湾、807
- Kaohsiung Medical University
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 20-30-yrs healthy students
Exclusion Criteria:
- Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, renal stones;
- Family history of renal stones;
- Body weight less than 50 kg.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:One big bag, no stainless container
No stainless container
|
|
|
有源比较器:One big bag with two stainless containers
Two stainless containers
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Decrease melamine excretion
大体时间:3 days
|
3 days
|
合作者和调查者
调查人员
- 首席研究员:Ming-Tsang Wu, MD, ScD、Kaohsiung Medical University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KMU-DT103004 (其他标识符:Kaohsiung Medical University Hospital)
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