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

Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Individuals

Intervention: vegetables from fresh or recycled water (Other); receives vegetables from fresh water or recycled waste water farms (Other)

Phase: N/A

Status: Completed

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Ora Paltiel, MDCM, Principal Investigator, Affiliation: Hadassah Medical Organization

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Primary outcome: mean urine carbamazepine level in parts per billion

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.

Eligibility

Minimum age: 18 Years. Maximum age: 68 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- men and women

- age 18-68

Exclusion Criteria:

- ingestion of carbamazepine,

- pregnancy

- vegetarian

- pure organic diet

Locations and Contacts

Hadassah Medical Organization, Jerusalem 91120, Israel
Additional Information

Starting date: September 2014
Last updated: August 19, 2015

Page last updated: August 23, 2015

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