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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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