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Immunological Indices and Infections Among Pesticide Applicators in Sohag Governorate

Primary Purpose

Pesticide Adverse Reaction

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Blood sample test

About this trial

This is an interventional diagnostic trial for Pesticide Adverse Reaction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: pesticide applicators Age ;20-60 years Exposure to pesticides for more than 3 months Exclusion Criteria: Subjects have recent severe trauma or surgery or recent infections

Sites / Locations

Sohag University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

pesticide applicators

control

Arm Description

This group contain cases

control group

Outcomes

Primary Outcome Measures

immunlogical indices

immunoglobulins (IgG ,IgE)

Secondary Outcome Measures

Full Information

NCT ID

NCT05828563

First Posted

April 13, 2023

Last Updated

April 13, 2023

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05828563

Brief Title

Immunological Indices and Infections Among Pesticide Applicators in Sohag Governorate

Official Title

Immunological Indices and Infections Among Pesticide Applicators in Sohag Governorate

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 1, 2023 (Anticipated)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The human body gets exposure to pesticides either directly or indirectly. By using pesticides on crops, humans come in direct contact with them and they affect the heaith Immune system is the first defense line against pathogenic organisms; however, it is altered by the vulnerable environmental factors such as pesticides, which can cause structural or functional alterations in humoral or cell mechanisms (nonspecific or adaptive) of the immune response which lead to an increase in the susceptibility to infections

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pesticide Adverse Reaction

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

pesticide applicators

Arm Type

Active Comparator

Arm Description

This group contain cases

Arm Title

control

Arm Type

Active Comparator

Arm Description

control group

Intervention Type

Diagnostic Test

Intervention Name(s)

Blood sample test

Intervention Description

Blood sample will be taken to determine immunological indices

Primary Outcome Measure Information:

Title

immunlogical indices

Description

immunoglobulins (IgG ,IgE)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: pesticide applicators Age ;20-60 years Exposure to pesticides for more than 3 months Exclusion Criteria: Subjects have recent severe trauma or surgery or recent infections

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

yara M Ahmed, demonstrator

Phone

01019246020

yaramohamed@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Nada A Mohamad, Professor

Phone

01116669244

nada_abdelaziz@med.sohag.edu.eg

Facility Information:

Facility Name

Sohag University

City

Sohag

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magdy M Amin, Professor

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

12708230

Citation

Hadnagy W, Leng G, Sugiri D, Ranft U, Idel H. Pyrethroids used indoors--immune status of humans exposed to pyrethroids following a pest control operation--a one year follow-up study. Int J Hyg Environ Health. 2003 Mar;206(2):93-102. doi: 10.1078/1438-4639-00201.

Results Reference

background

PubMed Identifier

34150527

Citation

Kalyabina VP, Esimbekova EN, Kopylova KV, Kratasyuk VA. Pesticides: formulants, distribution pathways and effects on human health - a review. Toxicol Rep. 2021 Jun 6;8:1179-1192. doi: 10.1016/j.toxrep.2021.06.004. eCollection 2021.

Results Reference

background

PubMed Identifier

32292398

Citation

Zhang W, Lin Z, Pang S, Bhatt P, Chen S. Insights Into the Biodegradation of Lindane (gamma-Hexachlorocyclohexane) Using a Microbial System. Front Microbiol. 2020 Mar 27;11:522. doi: 10.3389/fmicb.2020.00522. eCollection 2020.

Results Reference

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Learn more about this trial

Immunological Indices and Infections Among Pesticide Applicators in Sohag Governorate

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