NCT05094076

Brief 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. To our knowledge no local previous studies were done in this area.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 26, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

September 28, 2021

Last Update Submit

October 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • dental caries

    through study completion, an average of 1 year

Interventions

chest x rayRADIATION

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

Also known as: spirometer

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Active working miners working in phosphate mines with minimum exposure 5 year.

You may qualify if:

  • Active working miners working in phosphate mines with minimum exposure 5 year.
  • Had free pre-employment records.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 31289975BACKGROUND
  • 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.

    PMID: 24849681BACKGROUND
  • 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.

    PMID: 22102308BACKGROUND
  • 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.

    PMID: 11563682BACKGROUND

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 26, 2021

Study Start

January 1, 2022

Primary Completion

January 30, 2023

Study Completion

December 30, 2023

Last Updated

October 26, 2021

Record last verified: 2021-09