Urine Drug Levels Related to Source of Water for Irrigation for Vegetable Crops Among Healthy Israeli Volunteers
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
- 是
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
receives vegetables from freshwater farms
干预措施: vegetables from fresh or recycled water (Other)
freshwater
receives vegetables from freshwater farms
干预措施: receives vegetables from fresh water or recycled waste water farms (Other)
recycled wastewater
receives vegetables from farms using recycled wastewater irrigation
干预措施: vegetables from fresh or recycled water (Other)
recycled wastewater
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
