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

Healthy Individuals Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101801
• Other study ID #: orap2014-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: February 27, 2014
• Last updated: April 8, 2018
• Start date: September 2014
• Est. completion date: March 29, 2016

Study information

• Verified date: August 2015
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 29, 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

Inclusion Criteria:

• men and women

• age 18-68

Exclusion Criteria:

• ingestion of carbamazepine,

• pregnancy

• vegetarian

• pure organic diet

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Other:
• vegetables from fresh or recycled water

• receives vegetables from fresh water or recycled waste water farms

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean urine carbamazepine level in parts per billion	Urine will be tested on days -3,0,4,8	two weeks