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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Individuals
• Intervention / Treatment: Other: vegetables from fresh or recycled water; Other: receives vegetables from fresh water or recycled waste water farms

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• men and women
• age 18-68

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: freshwater; receives vegetables from freshwater farms	Other: vegetables from fresh or recycled water; Other: receives vegetables from fresh water or recycled waste water farms
Active Comparator: recycled wastewater; receives vegetables from farms using recycled wastewater irrigation	Other: vegetables from fresh or recycled water; Other: receives vegetables from fresh water or recycled waste water farms

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Ora Paltiel, MDCM, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 29, 2016

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: March 30, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 8, 2018
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: environment, recycled wastewater, carbamazepine
• Other Study ID Numbers: orap2014-HMO-CTIL