NCT02101801

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2016

Completed
Last Updated

April 10, 2018

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

February 27, 2014

Last Update Submit

April 8, 2018

Conditions

Healthy Individuals

Keywords

environment, recycled wastewater, carbamazepine

Outcome Measures

Primary Outcomes (1)

  • mean urine carbamazepine level in parts per billion

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

    two weeks

Study Arms (2)

freshwater

OTHER

receives vegetables from freshwater farms

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

recycled wastewater

ACTIVE COMPARATOR

receives vegetables from farms using recycled wastewater irrigation

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

Interventions

vegetables from fresh or recycled waterOTHER
freshwaterrecycled wastewater
receives vegetables from fresh water or recycled waste water farmsOTHER
freshwaterrecycled wastewater

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women
  • age 18-68

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Study Officials

  • Ora Paltiel, MDCM

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

April 2, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 29, 2016

Last Updated

April 10, 2018

Record last verified: 2015-08

Locations

IL(1)