- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05094076
Effect of Phosphate Exposure on Workers Health
Effect of Phosphate Exposure on Workers Respiratory and Oral Health in Phosphate Mine at Safaga
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Active working miners working in phosphate mines with minimum exposure 5 year.
- Had free pre-employment records.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dental caries
Time Frame: through study completion, an average of 1 year
|
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
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Khelifi 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.
- 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.
- Amin 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Phosphate exposure
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
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