Urine Drug Levels Related to Source of Water for Irrigation for Vegetable Crops Among Healthy Israeli Volunteers
研究概览
地位
条件
详细说明
40 healthy volunteers will undergo a food frequency questionnaire and ask to undergo a daily food diary.They will also be asked about drug exposure.
At baseline they will provide a urine and hair sample to determine presence of pharmaceuticals.
They will then undergo a crossover trial wih one week exposure to vegetables grown in recycled waste water or fresh water, with a three day wash out period. Participants will be asked to ingest a minimal amount of lettuce, carrots, peppers, tomatoes and lettuce during the study period.
During this period questionnaires will continue and urine samples will be collected every three days. The first compound to be tested will be carbamazepine, as it is stable in water.
It is important to note that vegetables provided to the participants are available in regular grocery stores.
Participants will be asked to drink bottled water throughout the study period . A sample of their home drinking water will also be tested for Carbamazepine as will a sample of the vegetables they consume.
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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Jerusalem、以色列、91120
- Hadassah Medical Organization
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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:
- men and women
- age 18-68
Exclusion Criteria:
- ingestion of carbamazepine,
- pregnancy
- vegetarian
- pure organic diet
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 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 |
|---|---|
|
其他:freshwater
receives vegetables from freshwater farms
|
|
|
有源比较器:recycled wastewater
receives vegetables from farms using recycled wastewater irrigation
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
mean urine carbamazepine level in parts per billion
大体时间:two weeks
|
Urine will be tested on days -3,0,4,8
|
two weeks
|
合作者和调查者
调查人员
- 首席研究员:Ora Paltiel, MDCM、Hadassah Medical Organization
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 (实际的)
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
- orap2014-HMO-CTIL
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