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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Healthy Individuals

Intervention / Treatment
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* Other: vegetables from fresh or recycled water
* Other: receives vegetables from fresh water or recycled waste water farms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age 18-68 Exclusion Criteria: ingestion of carbamazepine, pregnancy vegetarian pure organic diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: freshwater<br>receives vegetables from freshwater farms | Other: vegetables from fresh or recycled water<br> <br> Other: receives vegetables from fresh water or recycled waste water farms<br> <br> |
| Active Comparator: recycled wastewater<br>receives vegetables from farms using recycled wastewater irrigation | Other: vegetables from fresh or recycled water<br> <br> Other: receives vegetables from fresh water or recycled waste water farms<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean urine carbamazepine level in parts per billion | Urine will be tested on days -3,0,4,8 | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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environment, recycled wastewater, carbamazepine