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

Hadassah Medical Center

Status: Completed

Conditions: Healthy Individuals

Treatments: Other: vegetables from fresh or recycled water; Other: receives vegetables from fresh water or recycled waste water farms

Study type: Interventional

Funder types: Other

Identifiers

NCT02101801

orap2014-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• men and women
• age 18-68

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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35 participants in 2 patient groups

freshwater

Other group

Description:

receives vegetables from freshwater farms

Treatment:

Other: vegetables from fresh or recycled water

Other: receives vegetables from fresh water or recycled waste water farms

recycled wastewater

Active Comparator group

Description:

receives vegetables from farms using recycled wastewater irrigation

Treatment:

Other: vegetables from fresh or recycled water

Other: receives vegetables from fresh water or recycled waste water farms