Healthy IndividualsNCT02101801
Urine Drug Levels Related to Source of Water for Irrigation for Vegetable Crops Among Healthy Israeli Volunteers
A study testing vegetables from fresh or recycled water and receives vegetables from fresh water or recycled waste water farms in people with Healthy Individuals, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- vegetables from fresh or recycled water and receives vegetables from fresh water or recycled waste water farms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to 29 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women
- age 18-68
Who cannot join
- ingestion of carbamazepine,
- pregnancy
- vegetarian
- pure organic diet
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Individuals
- Being tested
- vegetables from fresh or recycled water, receives vegetables from fresh water or recycled waste water farms
- Keywords
- environment, recycled wastewater, carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vegetables from fresh or recycled waterOther
receives vegetables from fresh water or recycled waste water farmsOther
| Study group | Role | What they receive |
|---|---|---|
| freshwater | Other | receives vegetables from freshwater farms Receives: Other: vegetables from fresh or recycled water; Other: receives vegetables from fresh water or recycled waste water farms |
| recycled wastewater | Active comparator | receives vegetables from farms using recycled wastewater irrigation Receives: Other: vegetables from fresh or recycled water; Other: receives vegetables from fresh water or recycled waste water farms |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean urine carbamazepine level in parts per billion
Urine will be tested on days -3,0,4,8
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completion29 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ora Paltiel, MDCM, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101801
- Sponsor's protocol ID
- orap2014-HMO-CTIL
- Status last verified
- Aug 2015
- First submitted
- 27 Feb 2014
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Drug Levels Related to Source of Water for Irrigation for Vegetable Crops Among Healthy Israeli Volunteers
- ClinicalTrials.gov ID
- NCT02101801
- Acronym / sponsor ID
- orap2014-HMO-CTIL
- Conditions
- Healthy Individuals
- Keywords
- environment, recycled wastewater, carbamazepine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- 29 Mar 2016 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| freshwater | Other | Other: vegetables from fresh or recycled water, Other: receives vegetables from fresh water or recycled waste water farmsreceives vegetables from freshwater farms |
| recycled wastewater | Active comparator | Other: vegetables from fresh or recycled water, Other: receives vegetables from fresh water or recycled waste water farmsreceives vegetables from farms using recycled wastewater irrigation |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men and women
- age 18-68
Key exclusion criteria (4 listed)
- ingestion of carbamazepine,
- pregnancy
- vegetarian
- pure organic diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vegetables from fresh or recycled water | Other | freshwater, recycled wastewater |
| receives vegetables from fresh water or recycled waste water farms | Other | freshwater, recycled wastewater |
Primary outcome
mean urine carbamazepine level in parts per billion
Time frame: two weeks
Urine will be tested on days -3,0,4,8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ora Paltiel, MDCM principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vegetables from fresh or recycled water and receives vegetables from fresh water or recycled waste water farms in people with Healthy Individuals, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean urine carbamazepine level in parts per billion (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.