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

Not Applicable

Completed

• Conditions: Healthy Individuals
• Interventions: Other: vegetables from fresh or recycled water; Other: receives vegetables from fresh water or recycled waste water farms

• Registration Number: NCT02101801
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-03-30
• Study First Posted: 2014-04-02
• Study Start: 2014-09
• Primary Completion: 2014-12
• Status Verified: 2015-08
• Study Completion: 2016-03-29
• Last Update Submitted: 2018-04-08
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• men and women
• age 18-68

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
recycled wastewater	vegetables from fresh or recycled water	receives vegetables from farms using recycled wastewater irrigation
freshwater	receives vegetables from fresh water or recycled waste water farms	receives vegetables from freshwater farms
freshwater	vegetables from fresh or recycled water	receives vegetables from freshwater farms
recycled wastewater	receives vegetables from fresh water or recycled waste water farms	receives vegetables from farms using recycled wastewater irrigation

Primary Outcome Measures

Name	Time	Method
mean urine carbamazepine level in parts per billion	two weeks	Urine will be tested on days -3,0,4,8

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel