跳至主要内容
临床试验/NCT02101801
NCT02101801已完成不适用

Urine Drug Levels Related to Source of Water for Irrigation for Vegetable Crops Among Healthy Israeli Volunteers

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年9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
入组人数
35
试验地点
2
主要终点
mean urine carbamazepine level in parts per billion

研究概览

简要总结

Over 60% of crops in Israel are grown in recycled treated waste water. This study aims to determine whether minute quantities of drugs such as Carbamazepine can be found in individuals who ingest vegetables grown in waste water.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women
  • age 18-68

排除标准

  • ingestion of carbamazepine,
  • pregnancy
  • vegetarian
  • pure organic diet

研究组 & 干预措施

freshwater

Other

receives vegetables from freshwater farms

干预措施: vegetables from fresh or recycled water (Other)

freshwater

Other

receives vegetables from freshwater farms

干预措施: receives vegetables from fresh water or recycled waste water farms (Other)

recycled wastewater

Active Comparator

receives vegetables from farms using recycled wastewater irrigation

干预措施: vegetables from fresh or recycled water (Other)

recycled wastewater

Active Comparator

receives vegetables from farms using recycled wastewater irrigation

干预措施: receives vegetables from fresh water or recycled waste water farms (Other)

结局指标

主要结局

mean urine carbamazepine level in parts per billion

时间窗: two weeks

Urine will be tested on days -3,0,4,8

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验