- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06188312
Occupational Hazards Among Workers of Superphosphate Fertilizer Factory
January 20, 2024 updated by: Israa salah El-Din Shaker, Assiut University
Main Occupational Health Hazards Among Workers Of Superphosphate Fertilizer Factory in Assiut and Evaluation of a Health Education Program On Dangers of Respirable Chemicals.
The study aims:
- To identify the main occupational health hazards to which the superphosphate fertilizer industry workers are exposed.
- To identify the respiratory and auditory health effects of these hazards and associated risk factors among those workers.
- To clarify the knowledge, attitudes, and practices of workers towards the chemical health hazards affecting the respiratory system (dust and hazardous gases).
- To assess the effect of health education program on workers' knowledge, attitudes, and practices towards these hazards and the use of personal protective equipment (PPE).
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Fertilizers are compounds that provide nutrients to plants to increase and maintain maximum crop yield.
They are classified as organic, inorganic, or chemical fertilizers.
Organic fertilizers are by-products of livestock, fish, and food.
Chemical fertilizers (CFs) are manufactured using different proportions of major and minor chemical nutrients.
Although the use of fertilizers in the agricultural sector is inevitable to meet increasing food demand, the production of fertilizers and by-products poses health and safety challenges.
Two basic types of fertilizers are produced by Egyptian companies, which include nitrogenous and phosphate fertilizers (PF).
Normal superphosphate (NSP) is manufactured from the reaction between phosphate rocks (PR) and sulfuric acid.
There are some side chemical reactions involving fluorine and silica of PR producing H2SiF6 (fluorosilicic acid) and other hydrogen fluorides.
PF industry is one of the most environmentally polluting industries in Egypt.
Workers in the PF industry are exposed to many chemical and physical hazards.
Hazardous gas emissions include gaseous fluorides in the form of hydrofluoric acid (HF) and silicon tetrafluoride (SiF4), and sulfur dioxide (SO2).
SO2 is one of the five major air pollutants in the world .
It is an irritant gas that causes changes in the mechanical functions of the upper airways of the lung, resulting in bronchitis, and bronchoconstriction.
Sulfuric acid mists also irritate the human airways causing pulmonary epithelium damage.
Chronic fluoride exposure is characterized by accumulation mainly in hard tissues such as teeth and bones in the form of bone deformities (skeletal fluorosis) and dental mottling (dental fluorosis), and non-skeletal fluorosis (other system manifestations such as respiratory manifestations such as asthma.
In Egypt, a descriptive study was conducted on 180 exposed workers in a phosphate fertilizer factory at Kafr El-Zayat City, revealed that self-reported respiratory manifestations were found in 74/180 workers (41.11%) and abnormal ventilatory functions were confirmed in (43/180, 23.9%) with a prominence of the obstructive pattern .
Noise is one of the most important physical hazards in the fertilizer industry that has become a major problem in all industrial sectors.
An unmatched case-control study was carried out among fertilizer factory workers in Malaysia, revealed that cases were at 3.5 times greater risk of being exposed to more than 85 dB compared to the control.
There is a lack of published research assessing the occupational health problems among workers in the phosphate fertilizer industry in Upper Egypt and especially in Assiut.
Study Type
Observational
Enrollment (Estimated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Israa Salah El Din, Ass.Lect
- Phone Number: 01099633640
- Email: israa.s.shaker@med.aun.edu.eg
Study Contact Backup
- Name: Shimaa Abd El Samee, Ass.Prof
- Phone Number: 01000525137
- Email: shima_dola@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Phase one(survey): The total number of workers in the factory is 660.They were classified according to the levels of exposure to high exposure (including the production and engineering sectors) and low exposure (including the administrative sector).
- The high exposure group represented 76 % of workers [58% (380 workers) of the production workers and 18% (120 workers) of the engineering sector].
- The low exposure group represented 24% (160 workers) of the administrative sector.
Description
Inclusion Criteria:
All workers in the superphosphate fertilizer factory with a duration of work more than one year.
Exclusion Criteria:
- Workers who had history of any chronic respiratory diseases before employment, and those who had history of hearing loss before employment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence of respiratory and auditory problems among workers of the superphosphate fertilizer factory.
Time Frame: 1-1-2024 to 1-6-2024
|
percentage of workers who had respiratory and auditory affection
|
1-1-2024 to 1-6-2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean score difference of knowledge, attitudes, and practices before and after the health education program among workers of the superphosphate fertilizer factory.
Time Frame: 1-6-2024 to 1-12-2024
|
mean difference of knowledge, attitudes, and practicesof the workers before and after application of the health education program
|
1-6-2024 to 1-12-2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Israa Salah El Din, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chien, S. H., Prochnow, L. I. & Cantarella, H. (2009) Chapter 8 Recent Developments of Fertilizer Production and Use to Improve Nutrient Efficiency and Minimize Environmental Impacts, Advances in AgronomyAcademic Press, 267-322.
- Huda, N. U. & Territory, I. C. (2022) REVIEW ON OCCUPATIONAL HEALTH AND SAFETY ISSUES IN FERTILIZER INDUSTRY.
- Leikam, D. F. & Achorn, F. P. (2005) Phosphate fertilizers: production, characteristics, and technologies. Phosphorus: Agriculture and the environment, 46, 23-50.
- Geravandi, S., Goudarzi, G., Babaei, A. A., Takdastan, A., Mohammadi, M. J., Niri, M. V., Salmanzadeh, S. & Shirbeigi, E. (2015) Health endpoint attributed to sulfur dioxide air pollutants. Jundishapur Journal of Health Sciences, 7(3).
- Zayed HA, Salah N, Hassan NM, Elmagid DA. Assessment of respiratory health and environmental safety measures in phosphate fertilizer industry in the middle region of the Nile Delta, Egypt. Environ Sci Pollut Res Int. 2020 Oct;27(28):35008-35016. doi: 10.1007/s11356-020-09817-7. Epub 2020 Jun 25.
- Saffree Jeffree M, Ismail N, Awang Lukman K. Hearing impairment and contributing factors among fertilizer factory workers. J Occup Health. 2016 Sep 30;58(5):434-443. doi: 10.1539/joh.16-0043-OA. Epub 2016 Aug 4.
- Komarnisky LA, Christopherson RJ, Basu TK. Sulfur: its clinical and toxicologic aspects. Nutrition. 2003 Jan;19(1):54-61. doi: 10.1016/s0899-9007(02)00833-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
December 18, 2023
First Submitted That Met QC Criteria
December 18, 2023
First Posted (Actual)
January 3, 2024
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 20, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Israa.S.Shaker
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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