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CompletedNCT02101801Updated Apr 10, 2018

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

An interventional study of vegetables from fresh or recycled water and receives vegetables from fresh water or recycled waste water farms in Healthy Individuals, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 18 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 68 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Individuals

Keywords

  • environment, recycled wastewater, carbamazepine
03

In context

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 68 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • men and women
  • age 18-68

Exclusion criteria

Exclusion Criteria:

  • ingestion of carbamazepine,
  • pregnancy
  • vegetarian
  • pure organic diet
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
35 participants (actual)

Study arms

  • 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

Interventions

  • Othervegetables from fresh or recycled water
  • Otherreceives vegetables from fresh water or recycled waste water farms
06

What researchers measure

Primary outcomes

  1. mean urine carbamazepine level in parts per billion

    Urine will be tested on days -3,0,4,8

    Time frame: two weeks

07

Study locations

1 site
  • Hadassah Medical Organization
    Jerusalem, 91120, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02101801
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Apr 2, 2014
Start date
Sep 2014
Primary completion
Dec 2014
Completion
Mar 29, 2016
Last update
Apr 10, 2018

Study contacts

Ora Paltiel, MDCM
principal investigator · Hadassah Medical Organization

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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