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

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ClinicalTrials.gov Identifier: NCT02101801
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Individuals Other: vegetables from fresh or recycled water Other: receives vegetables from fresh water or recycled waste water farms Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 29, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. mean urine carbamazepine level in parts per billion [ Time Frame: two weeks ]
    Urine will be tested on days -3,0,4,8



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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • men and women
  • age 18-68

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101801


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Ora Paltiel, MDCM Hadassah Medical Organization

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02101801     History of Changes
Other Study ID Numbers: orap2014-HMO-CTIL
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: August 2015

Keywords provided by Hadassah Medical Organization:
environment, recycled wastewater, carbamazepine