Evaluation and comparison of mean serum IL-12 and CRP levels in staff at the gas station before and after giving omega-3 pills in Isfahan
Design
In this study, 60 employees of the gas station in Isfahan who have been entered into the study are randomly selected from different gas stations in the city of Isfahan. Participants are randomly divided into two intervention and control groups, and a file is maded for each case. Randomization method is random sampling method, clustering using random numbers table. This study is phase 3 clinical trial.
Settings and conduct
By random sampling, some gas stations are randomly selected from all parts of the city of Isfahan. The two groups in the study include gas station employees. In this study, the participant, researcher and evaluator of the outcome are kept blinded. The pills are in the same boxes, and the medication and placebo are coded so that the physician and the pharmacy and the patients do not know the codes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Employees who work at the gas station for at least one year and are willing to participate in the study. Those who have not the systemic inflammatory diseases before they work in a gas satation.
Exclusion criteria:
Employees who have changed their place of work or life less than one year of starting the study, at any time when one of the employees or members of the control group is not willing to participate in the research, If the subjects participating in the study suffer from another acute illness that increases the inflammatory factors of CRP and IL-12.
Intervention groups
Two groups are gas station staff. One of them receive omega-3 pills and another receive placebo.
Main outcome variables
Interleukin 12, C-reactive protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171215037878N1
Registration date:2018-02-08, 1396/11/19
Registration timing:registered_while_recruiting
Last update:2018-02-08, 1396/11/19
Update count:0
Registration date
2018-02-08, 1396/11/19
Registrant information
Name
Nafiseh Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
n_esmaeil@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of taking Omega-3 pill on serum level of Interleukin-12 (IL-12) and C-Reactive Protein (CRP) in gas station employees in Isfahan
Public title
Omega-3 effect on gas station employees
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Employees who have worked at the gas station for at least one year.
Satisfaction to participate in the study.
Exclusion criteria:
Having inflammatory systemic disease before working in a gas station
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random random sampling method, clustering using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participant, researcher and evaluator of the outcome are kept blinded. The pills are in the same boxes, and the medication and placebo are coded so that the physician and the pharmacy and the patients do not know the codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-01-29, 1395/11/10
Ethics committee reference number
Ir.mui.rec.1395.2.132
Health conditions studied
1
Description of health condition studied
Systemic inflammatory diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Timepoint
Method of measurement
2
Description
Interleukin 12
Timepoint
At the beginning of the study, two months after taking omega-3 pills or placebo
Method of measurement
ELISA test
3
Description
C-reactive protein
Timepoint
At the beginning of the study, two months after taking omega-3 pills or placebo
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Omega-3 pills, 3 times a day, for 2 months, orally
Category
Treatment - Drugs
2
Description
Control group: Placebo pills, 3 times a day, for 2 months, orally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Different gas stations in Isfahan city
Full name of responsible person
Nafiseh Esmaeili
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
n_esmaeil@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
empty
Title of funding source
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Atar
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
n_esmaeil@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nafiseh Esmaeili
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
n_esmaeil@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nafiseh Esmaeili
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 36680048
Email
n_esmaeil@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nafiseh Esmaeili
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 36680048
Email
n_esmaeil@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available