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
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