Respiratory DiseaseNCT05374148
Respiratory Health Problems Among Workers in Ferrosilicon Alloys Industry in Aswan-Eygpt.
An observational study of Respiratory Disease, run by Assiut University.
Trial summary
To minimize the negative effects of exposure to silica, iron chips, and coke on the respiratory health of workers in the Ferro alloy factory, so it is important to assess and diagnose their health-related effects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- health education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Oct 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 to 60 years
- All sexes
- Adult
Study population: workers exposed to free silica who have a free pre-employment records
Who may be able to join
- Active working miners working in ferrosilicon alloy factory with minimum exposure 5 years.
- Workers exposed to silica, iron chips, and coke in quarry and Furnaces areas.
- Have free pre-employment records especially free chest x-rays. have no previous pre- employment history of any chest problems.
Who cannot join
- • Workers don't record silica, iron chips, and coke exposer as in the administration department.
- Workers with less than 5-year exposure.
- Workers are known to have chest diseases before joining the work for example emphysema and COPD.
Trial locations and contacts
No sites are listed yet.
About this study
To minimize the negative effects of exposure to silica, iron chips, and coke on the respiratory health of workers in the Ferro alloy factory, so it is important to assess and diagnose their health-related effects. Early reporting, diagnosis, and intervention can limit the severity of health hazards, improve health services. To our knowledge, no local previous studies were done in this area. All over the world there is no sufficient information relating to this industry and its health hazards.
Read the detailed description
Ferrosilicon alloy is a mixture of iron and silicon. It's added to steel and cast iron. By oxidation of the iron, it offers superior properties to iron such as high strength, hardness, and resistance to corrosion and high temperatures. Around 90% of ferrosilicon alloys is consumed in the production of iron and steel. Silica dust is a secondary product of ferrosilicon industry. Its addition to concrete improve its chemical and physical properties[1] .
Ferrosilicon is an alloy of iron and silicon with high silicon content. Ferrosilicon alloys are produced in electric arc furnaces. At very high temperatures (2000°C). These furnaces are charged with quartz which is the main source of silica, iron chips, and coke which is used as a reducing agent. The industry process produces very fine particles of amorphous silica (SiO 2) powder(fume). The composition of the fumes varies somewhat according to which alloy is produced. In the production of ferrosilicon alloy with a high silicon content, the amount of Si02 in the fumes can be 80% or more[2].
Workers in the ferroalloy industry have been exposed to a variety of gases, fumes, and dust that may adversely affect the respiratory system. Among employees in Ferrosilicon plants, there is an increase in mortality rate from bronchitis, emphysema, and asthma[3]. Occupational exposure to respirable crystalline silica (SiO2) is one of the most common and serious hazards. It is considered a serious hazard for the ferrosilicon industry. Silicosis is the disease most associated with crystalline silica exposure. It causes by the inhalation of respirable crystalline silica dust [4]. It is a fibrotic lung disease progressive, irreversible, [5]. It is incurable but preventable[6]. Chronic Silicosis occurs due to the prolonged inhalation of respirable crystalline silica dust [4]. The major risk factors for developing silicosis include cumulative lifetime exposure, the total amount of inhaled crystalline Silica, silica size(0.5-3 µ) and individual susceptibility [6]. Thus, making silica dust one of the greater public health problems.
Silicosis is considered one of the most serious occupational diseases in the world. According to many previous studies, a large number of workers are exposed to silica dust throughout the world. At least 3.2 million workers in Europe and more than 2 million in the United States are exposed to silica dust[4] . In Asia, the prevalence of silicosis is up to 55% among workers exposed to silica dust, while in Latin America, the prevalence is up to 37%[8] In Egypt ,the prevalence rate of silicosis ranges from 18.5 % to 45.8% among workers exposed to free crystalline silica dust[9] Although many studies illustrated the relationship between silica exposure and silicosis occurrence in a different industries , there are no sufficient studies relating to the ferrosilicon industry and its respiratory hazards.
- Conditions
- Respiratory Disease
- Being tested
- health education
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationBehavioural
health education to prevent respiratory diseases among workers
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence
prevalence of silicosis among ferrosilicon industry workers.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Bazied Dardir mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374148
- Sponsor's protocol ID
- Respiratory ferrosilicon
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalliny MS, Bassyouni MI. Immune response due to silica exposure in Egyptian phosphate mines. J Health Care Poor Underserved. 2011;22(4 Suppl):91-109. doi: 10.1353/hpu.2011.0156.
PubMed 22102308Leung CC, Yu IT, Chen W. Silicosis. Lancet. 2012 May 26;379(9830):2008-18. doi: 10.1016/S0140-6736(12)60235-9. Epub 2012 Apr 24.
PubMed 22534002
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Health Problems Among Workers in Ferrosilicon Alloys Industry in Aswan-Eygpt.
- ClinicalTrials.gov ID
- NCT05374148
- Acronym / sponsor ID
- Respiratory ferrosilicon
- Conditions
- Respiratory Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 16 May 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.
To minimize the negative effects of exposure to silica, iron chips, and coke on the respiratory health of workers in the Ferro alloy factory, so it is important to assess and diagnose their health-related effects. Early reporting, diagnosis, and intervention can limit the severity of health hazards, improve health services. To our knowledge, no local previous studies were done in this area. All over the world there is no sufficient information relating to this industry and its health hazards.
Detailed description
Ferrosilicon alloy is a mixture of iron and silicon. It's added to steel and cast iron. By oxidation of the iron, it offers superior properties to iron such as high strength, hardness, and resistance to corrosion and high temperatures. Around 90% of ferrosilicon alloys is consumed in the production of iron and steel. Silica dust is a secondary product of ferrosilicon industry. Its addition to concrete improve its chemical and physical properties[1] .
Ferrosilicon is an alloy of iron and silicon with high silicon content. Ferrosilicon alloys are produced in electric arc furnaces. At very high temperatures (2000°C). These furnaces are charged with quartz which is the main source of silica, iron chips, and coke which is used as a reducing agent. The industry process produces very fine particles of amorphous silica (SiO 2) powder(fume). The composition of the fumes varies somewhat according to which alloy is produced. In the production of ferrosilicon alloy with a high silicon content, the amount of Si02 in the fumes can be 80% or more[2].
Workers in the ferroalloy industry have been exposed to a variety of gases, fumes, and dust that may adversely affect the respiratory system. Among employees in Ferrosilicon plants, there is an increase in mortality rate from bronchitis, emphysema, and asthma[3]. Occupational exposure to respirable crystalline silica (SiO2) is one of the most common and serious hazards. It is considered a serious hazard for the ferrosilicon industry. Silicosis is the disease most associated with crystalline silica exposure. It causes by the inhalation of respirable crystalline silica dust [4]. It is a fibrotic lung disease progressive, irreversible, [5]. It is incurable but preventable[6]. Chronic Silicosis occurs due to the prolonged inhalation of respirable crystalline silica dust [4]. The major risk factors for developing silicosis include cumulative lifetime exposure, the total amount of inhaled crystalline Silica, silica size(0.5-3 µ) and individual susceptibility [6]. Thus, making silica dust one of the greater public health problems.
Silicosis is considered one of the most serious occupational diseases in the world. According to many previous studies, a large number of workers are exposed to silica dust throughout the world. At least 3.2 million workers in Europe and more than 2 million in the United States are exposed to silica dust[4] . In Asia, the prevalence of silicosis is up to 55% among workers exposed to silica dust, while in Latin America, the prevalence is up to 37%[8] In Egypt ,the prevalence rate of silicosis ranges from 18.5 % to 45.8% among workers exposed to free crystalline silica dust[9] Although many studies illustrated the relationship between silica exposure and silicosis occurrence in a different industries , there are no sufficient studies relating to the ferrosilicon industry and its respiratory hazards.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- workers exposed to free silica who have a free pre-employment records
Key inclusion criteria (3 listed)
- Active working miners working in ferrosilicon alloy factory with minimum exposure 5 years.
- Workers exposed to silica, iron chips, and coke in quarry and Furnaces areas.
- Have free pre-employment records especially free chest x-rays. have no previous pre- employment history of any chest problems.
Key exclusion criteria (3 listed)
- • Workers don't record silica, iron chips, and coke exposer as in the administration department.
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 |
|---|---|---|
| health educationhealth education to prevent respiratory diseases among workers | Behavioural | – |
Primary outcome
prevalence
Time frame: 1 year
prevalence of silicosis among ferrosilicon industry workers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Background: PubMed 22102308Kalliny MS, Bassyouni MI. Immune response due to silica exposure in Egyptian phosphate mines. J Health Care Poor Underserved. 2011;22(4 Suppl):91-109. doi: 10.1353/hpu.2011.0156.
- Background: PubMed 22534002Leung CC, Yu IT, Chen W. Silicosis. Lancet. 2012 May 26;379(9830):2008-18. doi: 10.1016/S0140-6736(12)60235-9. Epub 2012 Apr 24.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Bazied, B.C.C.H (+201155836349, ala2238972@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374148, which also lists 2 linked publications.
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 16 May 2022.