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OpenTrials
Completed

NCT Number: NCT02101801

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

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.

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Key information

Conditions

Healthy Individuals

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men and women
  • age 18-68

Exclusion criteria

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

Treatment and study plan

vegetables from fresh or recycled water

Other

receives vegetables from fresh water or recycled waste water farms

Other

Primary outcomes

  1. mean urine carbamazepine level in parts per billion

    Time frame: two weeks

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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Apr 2, 2014
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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