HealthyNCT05256212
Occupational Exposure of Firefighters to Environmental Pollutants
An observational study of Healthy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The aim of the current trial is to assess the exposure of firefighters (FF) to environmental pollutants emitted from fires, to explore the association of exposure with their health status and to compare these data with those of non-FF participants Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- exposure to environmental contaminants
- How many people
- 108 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Aug 2017to 31 Dec 2023
- Phase
- Observational
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Firefighters
Who may be able to join
- active firefighters
Who cannot join
- Women
- firefighters with known liver, renal or thyroid problems
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current trial is to assess the exposure of firefighters (FF) to environmental pollutants emitted from fires, to explore the association of exposure with their health status and to compare these data with those of non-FF participants
Read the detailed description
Occupational exposure of firefighters to environmental contaminants Background Firefighters (FF) are exposed during their firefighting activities to a vast array of contaminants and toxic gases vapors that are released into the environment as results of combustion. Between those materials, there are heavy metals, brominated flame retardants (Polybrominated diphenyl ethers, PBDEs) and Volatile organic Compounds (VOC) that include between others Benzene, Toluene, Ethylbenzene and Xylene (BTEX).In the last decade a concern for negative health impact for all these contaminants appeared.
There is a vast use of these materials in the production of cars, furniture, electrical appliances, mattresses, paints, etc. These materials are released into the environment and absorbed by the human body.
There are some groups with increased exposure to these materials in comparison to the general population, as results of occupational exposure. Some of these groups include FF, workers who recycle electronic equipment and furniture manufacture workers.
Purposes:
- to measure the levels of PBDEs, heavy metals and BTEX metabolites in the blood and urine of FF who are exposed to fires during their work
- to evaluate the association between the levels of these materials and the health status of the participants. This will be done using a health questionnaire and the results of blood tests showing liver, renal and thyroid functions.
- to compare their exposure levels and health status with those of general population
This is a prospective observational trial in a FF group. Exposure data from the activity log for each of the FF will also be collected.
Bromide flame retardants PBDEs
These materials are added during the manufacture process to many products such as: plastic, textile, furnitures, mattresses and electric equipment in order to reduce their flammability.
There are 5 main groups of flame retardants and more than 75 different kinds. BSEF (2006) reported the highest consumption of decaBDE at 65.7 kt in 2002, The wide manufacture and use of PBDEs increases their release and their accumulation in the environment with time.
Although PBDEs increase the safety of products in times of fire, they can release unwanted byproducts such as: dibenzene dioxinbromide and dibenzenofuran bromide.
During the last years, there is an increasing concern re. the nocive effects of these materials when they accumulate in the body.
Earlier animal studies show toxic effects of flame retardants: developmental neurotoxicity, hormonal effects and morphological renal and liver changes.
Additional studies show effects on sex hormones, ano-genital distance, puberty onset and spermatogenesis.
VOC-BTEX: these are aromatic hydrocarbon compounds, widely used in industry. They are a significant part of the air pollutants.
They have low boiling point and their main way of exposure is via the air. Humans are exposed to them from different sources: cleaning products, paints, solvents, cosmetics, car exhaust gases and cigarettes smoking.
Exposure to VOC can increase risk of congenital malformations, neuro-cognitive impairment, asthma and cancer.
During combustion, VOC are released into the environment. They may harm many systems in the body: neural, respiratory, reproductive. They also harm the liver and are mutagenic and immunotoxic.
Heavy metals (HM)
Humans are exposed to HM via the air, water or food. At high levels, all HM can harm the lungs. Some of the HM are more harmful than others:
Lead -Pb is known for neurological and cognitive harmful effects. Can also harm red blood cells, aminoacids metabolism and other metabolic systems.
Mercury -Hg can harm CNS, kidneys and embryos. Short exposure at high levels may harm: lungs, blood tension and heartbeat, digestive system, skin and eyes.
Cadmium- Cd causes abortion and preterm deliveries and can cause acidosis. Chromium-Cr: hexavalent chromium may cause skin, eyes and respiratory problems. Chronic exposure can cause cancer.
Study Plan
- Trial population FF will be recruited (200). Exposure levels will be assessed for each participant by means of a detailed questionnaire. Levels of HM, PBDEs and BTEX found in blood and urine will be evaluated against health parameters such as: liver, renal and thyroid function, considering demographical , occupational and health variables (age, tenure, known diseases, eating habits, smoking and drinking.
- Data and specimen collection From each FF, urine and blood (30 cc) samples will be collected and keep refrigerated till arrival into the lab. Samples will be separated and the ones for pollutants analysis will be kept in deep freezer (-80C) till analyzed.
- Questionnaires FF will fill up specific questionnaires regarding demography, life-style, life habits during non-working hours. Basic health status, chronic diseases related to thyroid, fertility, psychological problems, both prescription and non-prescription drugs use.
- Occupational data General data is routinely collected at the FF station such as work procedures, drills, number of calls. In addition, personal data will be collected for each FF: tenure, shifts/year, fire calls or other calls/year, task at the station , etc.
- Lab tests:
Thyroid function: the following will be tested: 4-FT4; TSH; TPO-Ab Tg-Ab at Shamir MC central Lab using SOP Renal function: creatinine and GFR will be measured. Liver function: AST and ALT will be measured
PBDEs will be measured by GC-MS BTEX metabolites will be measured by LC-MS/MS Heavy Metals will be measured by ICP-MS
As a control group, samples collected in 12/12 trial (NCT03084445) that were not yet analyzed will be used. These samples were collected from men arriving to Shamir MC delivery room with their spouses.
- Conditions
- Healthy
- Being tested
- exposure to environmental contaminants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to environmental contaminantsOther
to measure levels of contaminants in different matrixes
| Study group | Role | What they receive |
|---|---|---|
| firefighters | firefighters in active service Receives: Other: exposure to environmental contaminants |
What is being measured
The primary outcome is the main question the study is designed to answer.
PBDEs levels, measured in serum by GC-MS
to test for PBDE levels in blood
Measured: Day 1- day of recruitment
BTEX levels, measured in urine by LC-MS/MS
to test for BTEX levels in blood
Measured: Day 1- day of recruitment
Heavy metals (Pb, Hg, Cd) levels, measured in urine by ICP-MS
to test for Heavy metals levels
Measured: Day 1- day of recruitment
Secondary outcomes (3)
Liver enzymes levels (x2 of Upper Limit of Normal), measured in serum
to test for liver function
Measured: Day 1- day of recruitment
renal function (eGFR<60), by creatinine level measured in serum
to test for renal function
Measured: Day 1- day of recruitment
Thyroid function (TSH or FT4 out of lab reference values) measured in serum
to test for thyroid function
Measured: Day 1- day of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start15 Aug 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Elkana Kohn, Assaf-Harofeh Medical Center
- Investigators
- Matityahu Berkovitch, Prof, Principal investigator, Shamir MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256212
- Sponsor's protocol ID
- 0167-17-ASF
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be shared as needed for QA purposes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Exposure of Firefighters to Environmental Pollutants
- ClinicalTrials.gov ID
- NCT05256212
- Acronym / sponsor ID
- 0167-17-ASF
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Feb 2022 (actual)
- 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.
The aim of the current trial is to assess the exposure of firefighters (FF) to environmental pollutants emitted from fires, to explore the association of exposure with their health status and to compare these data with those of non-FF participants
Detailed description
Occupational exposure of firefighters to environmental contaminants Background Firefighters (FF) are exposed during their firefighting activities to a vast array of contaminants and toxic gases vapors that are released into the environment as results of combustion. Between those materials, there are heavy metals, brominated flame retardants (Polybrominated diphenyl ethers, PBDEs) and Volatile organic Compounds (VOC) that include between others Benzene, Toluene, Ethylbenzene and Xylene (BTEX).In the last decade a concern for negative health impact for all these contaminants appeared.
There is a vast use of these materials in the production of cars, furniture, electrical appliances, mattresses, paints, etc. These materials are released into the environment and absorbed by the human body.
There are some groups with increased exposure to these materials in comparison to the general population, as results of occupational exposure. Some of these groups include FF, workers who recycle electronic equipment and furniture manufacture workers.
Purposes:
- to measure the levels of PBDEs, heavy metals and BTEX metabolites in the blood and urine of FF who are exposed to fires during their work
- to evaluate the association between the levels of these materials and the health status of the participants. This will be done using a health questionnaire and the results of blood tests showing liver, renal and thyroid functions.
- to compare their exposure levels and health status with those of general population
This is a prospective observational trial in a FF group. Exposure data from the activity log for each of the FF will also be collected.
Bromide flame retardants PBDEs
These materials are added during the manufacture process to many products such as: plastic, textile, furnitures, mattresses and electric equipment in order to reduce their flammability.
There are 5 main groups of flame retardants and more than 75 different kinds. BSEF (2006) reported the highest consumption of decaBDE at 65.7 kt in 2002, The wide manufacture and use of PBDEs increases their release and their accumulation in the environment with time.
Although PBDEs increase the safety of products in times of fire, they can release unwanted byproducts such as: dibenzene dioxinbromide and dibenzenofuran bromide.
During the last years, there is an increasing concern re. the nocive effects of these materials when they accumulate in the body.
Earlier animal studies show toxic effects of flame retardants: developmental neurotoxicity, hormonal effects and morphological renal and liver changes.
Additional studies show effects on sex hormones, ano-genital distance, puberty onset and spermatogenesis.
VOC-BTEX: these are aromatic hydrocarbon compounds, widely used in industry. They are a significant part of the air pollutants.
They have low boiling point and their main way of exposure is via the air. Humans are exposed to them from different sources: cleaning products, paints, solvents, cosmetics, car exhaust gases and cigarettes smoking.
Exposure to VOC can increase risk of congenital malformations, neuro-cognitive impairment, asthma and cancer.
During combustion, VOC are released into the environment. They may harm many systems in the body: neural, respiratory, reproductive. They also harm the liver and are mutagenic and immunotoxic.
Heavy metals (HM)
Humans are exposed to HM via the air, water or food. At high levels, all HM can harm the lungs. Some of the HM are more harmful than others:
Lead -Pb is known for neurological and cognitive harmful effects. Can also harm red blood cells, aminoacids metabolism and other metabolic systems.
Mercury -Hg can harm CNS, kidneys and embryos. Short exposure at high levels may harm: lungs, blood tension and heartbeat, digestive system, skin and eyes.
Cadmium- Cd causes abortion and preterm deliveries and can cause acidosis. Chromium-Cr: hexavalent chromium may cause skin, eyes and respiratory problems. Chronic exposure can cause cancer.
Study Plan
- Trial population FF will be recruited (200). Exposure levels will be assessed for each participant by means of a detailed questionnaire. Levels of HM, PBDEs and BTEX found in blood and urine will be evaluated against health parameters such as: liver, renal and thyroid function, considering demographical , occupational and health variables (age, tenure, known diseases, eating habits, smoking and drinking.
- Data and specimen collection From each FF, urine and blood (30 cc) samples will be collected and keep refrigerated till arrival into the lab. Samples will be separated and the ones for pollutants analysis will be kept in deep freezer (-80C) till analyzed.
- Questionnaires FF will fill up specific questionnaires regarding demography, life-style, life habits during non-working hours. Basic health status, chronic diseases related to thyroid, fertility, psychological problems, both prescription and non-prescription drugs use.
- Occupational data General data is routinely collected at the FF station such as work procedures, drills, number of calls. In addition, personal data will be collected for each FF: tenure, shifts/year, fire calls or other calls/year, task at the station , etc.
- Lab tests:
Thyroid function: the following will be tested: 4-FT4; TSH; TPO-Ab Tg-Ab at Shamir MC central Lab using SOP Renal function: creatinine and GFR will be measured. Liver function: AST and ALT will be measured
PBDEs will be measured by GC-MS BTEX metabolites will be measured by LC-MS/MS Heavy Metals will be measured by ICP-MS
As a control group, samples collected in 12/12 trial (NCT03084445) that were not yet analyzed will be used. These samples were collected from men arriving to Shamir MC delivery room with their spouses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| firefighters | – | Other: exposure to environmental contaminantsfirefighters in active service |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Firefighters
Key inclusion criteria (1 listed)
- active firefighters
Key exclusion criteria (2 listed)
- Women
- firefighters with known liver, renal or thyroid problems
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 |
|---|---|---|
| exposure to environmental contaminantsto measure levels of contaminants in different matrixes | Other | firefighters |
Primary outcome
PBDEs levels, measured in serum by GC-MS
Time frame: Day 1- day of recruitment
to test for PBDE levels in blood
BTEX levels, measured in urine by LC-MS/MS
Time frame: Day 1- day of recruitment
to test for BTEX levels in blood
Heavy metals (Pb, Hg, Cd) levels, measured in urine by ICP-MS
Time frame: Day 1- day of recruitment
to test for Heavy metals levels
3 secondary outcomes
Liver enzymes levels (x2 of Upper Limit of Normal), measured in serum
Time frame: Day 1- day of recruitment
renal function (eGFR<60), by creatinine level measured in serum
Time frame: Day 1- day of recruitment
Thyroid function (TSH or FT4 out of lab reference values) measured in serum
Time frame: Day 1- day of recruitment
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 31 Jul 2024.
- Individual participant dataSharing planned: Yes. IPD to be shared as needed for QA purposes
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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.
Matityahu Berkovitch, Prof principal investigator
Shamir MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Assaf-Harofeh Medical Center 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 1 inclusion and 2 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 31 Jul 2024. 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?
PBDEs levels, measured in serum by GC-MS (time frame: Day 1- day of recruitment). The study lists 3 primary outcomes in all. 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 31 Jul 2024.