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临床试验/NCT02251405
NCT02251405已完成不适用

Behaviour Intervention to Decrease Melamine Exposure

Ming-Tsang Wu2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Decrease melamine excretion

研究概览

简要总结

One source of melamine exposure in the modern life is from the use of melamine tableware. This study examines whether the use of stainless steel containers can decrease melamine exposure in the daily life. The investigators hypothesize that, compared to those without use of stainless steel containers, university student volunteers with use of stainless steel containers excrete significantly lower melamine levels in urine.

详细描述

Study subjects:

Two tiers:

  1. 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)
  2. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 20-30-yrs healthy students

排除标准

  • Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, renal stones;
  • Family history of renal stones;
  • Body weight less than 50 kg.

研究组 & 干预措施

One big bag, no stainless container

Placebo Comparator

No stainless container

干预措施: One bag, stainless container (Behavioral)

One big bag with two stainless containers

Active Comparator

Two stainless containers

干预措施: One bag, stainless container (Behavioral)

结局指标

主要结局

Decrease melamine excretion

时间窗: 3 days

次要结局

未报告次要终点

研究者

发起方
Ming-Tsang Wu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ming-Tsang Wu

Professor

Kaohsiung Medical University Chung-Ho Memorial Hospital

研究点 (2)

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