Work-related IllnessNCT05094076
Effect of Phosphate Exposure on Workers Health
An observational study of Work-related Illness, run by Assiut University.
Trial summary
To minimize negative health effects on health of workers in phosphate mining, it is important to assess, and diagnose health related effect of phosphate exposure \& health hazards related to miners. Early reporting, diagnosis, and intervention can limit the severity of health hazards, improve the health services. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Work-related Illness
- What is being tested?
- chest x ray
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 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 25 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Active working miners working in phosphate mines with minimum exposure 5 year.
Who may be able to join
- Active working miners working in phosphate mines with minimum exposure 5 year.
- Had free pre-employment records.
Who cannot join
- Workers don't record phosphate exposure as in administration department.
- Workers with less than 5-year exposure
- Workers known to had autoimmune disorder before joining job.
About this study
Official title: Effect of Phosphate Exposure on Workers Respiratory and Oral Health in Phosphate Mine at Safaga
To minimize negative health effects on health of workers in phosphate mining, it is important to assess, and diagnose health related effect of phosphate exposure \& health hazards related to miners. Early reporting, diagnosis, and intervention can limit the severity of health hazards, improve the health services. To our knowledge no local previous studies were done in this area.
Read the detailed description
Mining continues to be a dangerous activity, whether large-scale industrial mining or small-scale artisanal mining. Not only are there accidents, but exposure to dust and toxins, along with stress from the working environment or managerial pressures, give rise to a range of diseases that affect miners. Beneficiation is the process of removing the unnecessary minerals, which is used to increase the grade of mining product (concentrate). Phosphate ores can be beneficiated using one or a combination of different methods. The most common ones are: flotation, crushing, desliming, separation, grinding and washing thus keeping workers in Phosphate mines employ exposed to respirable dust pollution and to high silica dust levels presented in silicosis in many job areas, Silicosis is the most common occupational lung disease in Egypt where its prevalence rate ranges from 18.5 % to 45.8% among workers exposed to free crystalline silica dust. Despite its high prevalence, there is a lack of enforcement of exposure limits, availability and use of personal protective equipment, and occupational health education programs .
In Egyptian phosphate miners' study (2011), The study involved of three groups: 50 silica-exposed workers with radiological evidence of silicosis, 50 silica-exposed workers without evidence of silicosis, and 50 healthy unexposed subjects. , There were significant differences between pulmonary function parameters, values of C-reactive protein, rheumatoid factor, complement component C3, IgA, IgG, and IgM in exposed groups with and without silicosis, and healthy unexposed control subjects (p<.001).
Exposure to acid fumes in the phosphate mining was significantly associated with dental erosion and deteriorated oral health status, As working in phosphate mines had 8 and 28 times the risk for developing respectively oral lesions and teeth abrasions. This supported by Tunisian 2017 on 37 workers\& 37 controls, found that frequencies of fluorosis, teeth abrasion, and oral lesions were significantly higher among the exposed group.
- Conditions
- Work-related Illness
- Being tested
- chest x ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest x rayRadiation
Also called spirometer
The chest radiographs obtained will be classified according to the International Labor Organization (ILO) System for Classification of Radiographs for Pneumoconiosis [ILO, 1980]. Film quality, profusion, and shape and size of opacities will be evaluated by this method. Radiographic evidence of silicosis was defined as a profusion score of 1/0 or greater
What is being measured
The primary outcome is the main question the study is designed to answer.
pneumoconiosis or not
The chest radiographs obtained will be classified according to the International Labor Organization (ILO) System for Classification of Radiographs for Pneumoconiosis [ILO, 1980]. Film quality, profusion, and shape and size of opacities will be evaluated by this method. Radiographic evidence of silicosis was defined as a profusion score of 1/0 or greater
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
dental caries
The DMFT index is one of the simplest and most used indices in epidemiologic surveys of dental caries. It quantifies dental health status based on the number of carious, missing and filled teeth
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Work-related IllnessStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Roshdy Elkhayat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094076
- Sponsor's protocol ID
- Phosphate exposure
- Status last verified
- Sep 2021
- First submitted
- 28 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
Publications
Stewart AG. Mining is bad for health: a voyage of discovery. Environ Geochem Health. 2020 Apr;42(4):1153-1165. doi: 10.1007/s10653-019-00367-7. Epub 2019 Jul 9.
PubMed 31289975Khelifi M, Zarrouk A, Nury T, Hamed H, Saguem S, Salah RB, Riedinger JM, Lizard G. Cytokine and eicosanoid profiles of phosphate mine workers. J Toxicol Sci. 2014 Jun;39(3):465-74. doi: 10.2131/jts.39.465.
PubMed 24849681Kalliny 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 22102308Amin WM, Al-Omoush SA, Hattab FN. Oral health status of workers exposed to acid fumes in phosphate and battery industries in Jordan. Int Dent J. 2001 Jun;51(3):169-74. doi: 10.1002/j.1875-595x.2001.tb00835.x.
PubMed 11563682
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phosphate Exposure on Workers Respiratory and Oral Health in Phosphate Mine at Safaga
- ClinicalTrials.gov ID
- NCT05094076
- Acronym / sponsor ID
- Phosphate exposure
- Conditions
- Work-related Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 26 Oct 2021 (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 negative health effects on health of workers in phosphate mining, it is important to assess, and diagnose health related effect of phosphate exposure \& health hazards related to miners. Early reporting, diagnosis, and intervention can limit the severity of health hazards, improve the health services. To our knowledge no local previous studies were done in this area.
Detailed description
Mining continues to be a dangerous activity, whether large-scale industrial mining or small-scale artisanal mining. Not only are there accidents, but exposure to dust and toxins, along with stress from the working environment or managerial pressures, give rise to a range of diseases that affect miners. Beneficiation is the process of removing the unnecessary minerals, which is used to increase the grade of mining product (concentrate). Phosphate ores can be beneficiated using one or a combination of different methods. The most common ones are: flotation, crushing, desliming, separation, grinding and washing thus keeping workers in Phosphate mines employ exposed to respirable dust pollution and to high silica dust levels presented in silicosis in many job areas, Silicosis is the most common occupational lung disease in Egypt where its prevalence rate ranges from 18.5 % to 45.8% among workers exposed to free crystalline silica dust. Despite its high prevalence, there is a lack of enforcement of exposure limits, availability and use of personal protective equipment, and occupational health education programs .
In Egyptian phosphate miners' study (2011), The study involved of three groups: 50 silica-exposed workers with radiological evidence of silicosis, 50 silica-exposed workers without evidence of silicosis, and 50 healthy unexposed subjects. , There were significant differences between pulmonary function parameters, values of C-reactive protein, rheumatoid factor, complement component C3, IgA, IgG, and IgM in exposed groups with and without silicosis, and healthy unexposed control subjects (p<.001).
Exposure to acid fumes in the phosphate mining was significantly associated with dental erosion and deteriorated oral health status, As working in phosphate mines had 8 and 28 times the risk for developing respectively oral lesions and teeth abrasions. This supported by Tunisian 2017 on 37 workers\& 37 controls, found that frequencies of fluorosis, teeth abrasion, and oral lesions were significantly higher among the exposed group.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Active working miners working in phosphate mines with minimum exposure 5 year.
Key inclusion criteria (2 listed)
- Active working miners working in phosphate mines with minimum exposure 5 year.
- Had free pre-employment records.
Key exclusion criteria (3 listed)
- Workers don't record phosphate exposure as in administration department.
- Workers with less than 5-year exposure
- Workers known to had autoimmune disorder before joining job.
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 |
|---|---|---|
| chest x rayAlso: spirometerThe chest radiographs obtained will be classified according to the International Labor Organization (ILO) System for Classification of Radiographs for Pneumoconiosis [ILO, 1980]. Film quality, profusion, and shape and size of opacities will be evaluated by this method. Radiographic evidence of silicosis was defined as a profusion score of 1/0 or greater | Radiation | – |
Primary outcome
pneumoconiosis or not
Time frame: through study completion, an average of 1 year
The chest radiographs obtained will be classified according to the International Labor Organization (ILO) System for Classification of Radiographs for Pneumoconiosis [ILO, 1980]. Film quality, profusion, and shape and size of opacities will be evaluated by this method. Radiographic evidence of silicosis was defined as a profusion score of 1/0 or greater
1 secondary outcome
dental caries
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 31289975Stewart AG. Mining is bad for health: a voyage of discovery. Environ Geochem Health. 2020 Apr;42(4):1153-1165. doi: 10.1007/s10653-019-00367-7. Epub 2019 Jul 9.
- Background: PubMed 24849681Khelifi M, Zarrouk A, Nury T, Hamed H, Saguem S, Salah RB, Riedinger JM, Lizard G. Cytokine and eicosanoid profiles of phosphate mine workers. J Toxicol Sci. 2014 Jun;39(3):465-74. doi: 10.2131/jts.39.465.
- 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 11563682Amin WM, Al-Omoush SA, Hattab FN. Oral health status of workers exposed to acid fumes in phosphate and battery industries in Jordan. Int Dent J. 2001 Jun;51(3):169-74. doi: 10.1002/j.1875-595x.2001.tb00835.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Work-related Illness, 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 2 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 26 Oct 2021. 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?
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?
pneumoconiosis or not (time frame: through study completion, an average of 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 NCT05094076, which also lists 4 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 26 Oct 2021.