Occupational ExposureNCT06188312
Occupational Hazards Among Workers of Superphosphate Fertilizer Factory
An observational study of Occupational Exposure and Health Knowledge, Attitudes, Practice, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Occupational Exposure, Health Knowledge, Attitudes, Practice
- What is being tested?
- Health education program
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Feb 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All workers in the superphosphate fertilizer factory with a duration of work more than one year.
Who cannot join
- Workers who had history of any chronic respiratory diseases before employment, and those who had history of hearing loss before employment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Being tested
- Health education program
- Keywords
- superphosphate factory, Health hazards, Health education
- Medical subject headings
- Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education programOther
A pretest questionnaire will be filled out, asking the participants about their knowledge, attitudes, and practices toward chemical hazards and the use of personal protective equipment (PPE) then analysis of the obtained pre-test data will be done.
we will apply a health education program. Development phase: developing the message of the health education program and preparing the materials (slide presentation, brochures, and an educational video).Implementation phase: A group health education session through face-to-face, one hour long, interactive lecture combined with slide presentation will be carried out by the researcher. Evaluation phase: A post-test will be done, after 6 months of the first session, to assess the changes of their knowledge and attitude after the intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of respiratory and auditory problems among workers of the superphosphate fertilizer factory.
percentage of workers who had respiratory and auditory affection
Measured: 1-1-2024 to 1-6-2024
Secondary outcomes (1)
Mean score difference of knowledge, attitudes, and practices before and after the health education program among workers of the superphosphate fertilizer factory.
mean difference of knowledge, attitudes, and practicesof the workers before and after application of the health education program
Measured: 1-6-2024 to 1-12-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Occupational ExposureStudies 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Israa salah El-Din Shaker, Assiut University
- Investigators
- Israa Salah El Din, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188312
- Sponsor's protocol ID
- Israa.S.Shaker
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
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.
PubMed 32583121Huda, N. U. & Territory, I. C. (2022) REVIEW ON OCCUPATIONAL HEALTH AND SAFETY ISSUES IN FERTILIZER INDUSTRY.
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.
PubMed 27488035Komarnisky 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.
PubMed 12507640Leikam, 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).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Main Occupational Health Hazards Among Workers Of Superphosphate Fertilizer Factory in Assiut and Evaluation of a Health Education Program On Dangers of Respirable Chemicals.
- ClinicalTrials.gov ID
- NCT06188312
- Acronym / sponsor ID
- Israa.S.Shaker
- Keywords
- superphosphate factory, Health hazards, Health education
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 3 Jan 2024 (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.
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).
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All workers in the superphosphate fertilizer factory with a duration of work more than one year.
Key exclusion criteria (1 listed)
- Workers who had history of any chronic respiratory diseases before employment, and those who had history of hearing loss before employment.
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 education programA pretest questionnaire will be filled out, asking the participants about their knowledge, attitudes, and practices toward chemical hazards and the use of personal protective equipment (PPE) then analysis of the obtained pre-test data will be done. we will apply a health education program. Development phase: developing the message of the health education program and preparing the materials (slide presentation, brochures, and an educational video).Implementation phase: A group health education session through face-to-face, one hour long, interactive lecture combined with slide presentation will be carried out by the researcher. Evaluation phase: A post-test will be done, after 6 months of the first session, to assess the changes of their knowledge and attitude after the intervention. | Other | – |
Primary outcome
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 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- BackgroundChien, 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.
- Background: PubMed 32583121Zayed 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.
- BackgroundHuda, N. U. & Territory, I. C. (2022) REVIEW ON OCCUPATIONAL HEALTH AND SAFETY ISSUES IN FERTILIZER INDUSTRY.
- Background: PubMed 27488035Saffree 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.
- Background: PubMed 12507640Komarnisky 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.
- BackgroundLeikam, D. F. & Achorn, F. P. (2005) Phosphate fertilizers: production, characteristics, and technologies. Phosphorus: Agriculture and the environment, 46, 23-50.
- BackgroundGeravandi, 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).
- Elessent Clean Technologies (2023) Sulfuric Acid in the Phosphate Fertilizer Industry, 2023Link provided by the sponsor.
- 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.
Israa Salah El Din principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure and Health Knowledge, Attitudes, Practice, 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 1 inclusion and 1 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 23 Jan 2024. 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 Israa Salah El Din, Ass.Lect (01099633640, israa.s.shaker@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of respiratory and auditory problems among workers of the superphosphate fertilizer factory. (time frame: 1-1-2024 to 1-6-2024). 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 NCT06188312, which also lists 7 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 23 Jan 2024.