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HealthyNCT05256212

Occupational Exposure of Firefighters to Environmental Pollutants

An observational study of Healthy, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

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:

  1. 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
  2. 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.
  3. 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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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 groups in NCT05256212
Study groupRoleWhat they receive
firefightersfirefighters 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.

  1. PBDEs levels, measured in serum by GC-MS

    to test for PBDE levels in blood

    Measured: Day 1- day of recruitment

  2. BTEX levels, measured in urine by LC-MS/MS

    to test for BTEX levels in blood

    Measured: Day 1- day of recruitment

  3. 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)
  1. Liver enzymes levels (x2 of Upper Limit of Normal), measured in serum

    to test for liver function

    Measured: Day 1- day of recruitment

  2. renal function (eGFR<60), by creatinine level measured in serum

    to test for renal function

    Measured: Day 1- day of recruitment

  3. 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.

  1. First posted25 Feb 2022
  2. Study start15 Aug 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2023

Resources

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)
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

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.

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