Protocol summary

Study aim
The aim is determine the effect of E and C vitamins intervention on oxidative stress biomarkers, biochemical parameters, Anxiety, depression and stress in workers who exposure to cement dust.
Design
Clinical trial study with 2 group include main intervention group that use E and C vitamins and control intervention group that use placebo, Stratified randomized and double blind with parallel group and include 80 participants
Settings and conduct
Cement dust has many harmful effects on health, So we do this study in Fars cement plant in Shiraz, after choice participant by stratified randomized, Blood sampling perform at the beginning of the work shift at 7 morning. And assessing the oxidative stress level, biochemical parameters before intervention, Also DASS questionnaire filled out. Then vitamins and placebos gives to participants every day along 2 month by our assistant . Researcher and participants not aware of the process of intervention. After two month we will do blood sampling again and will compares the level of oxidative stress, biochemical parameters, with the amount of them before intervention.
Participants/Inclusion and exclusion criteria
Workers with any underlying disease including diabetes, hypertension, heart disease, and kidney disease Workers who take a particular drug or vitamins that has effect on intervention as well as those with less than 5 years job experience Workers who singe a written informed consent
Intervention groups
The main intervention group are participants that use E and C vitamins, And control intervention group are participants that use placebo
Main outcome variables
malondialdehyde, total antioxidant capacity, superoxide dismutase, catalase, silica, alkaline phosphatase, alanine transaminase, aspartate transaminase, high density lipid, low density lipid, triglyceride, total bilirubin, glucose, albumin, creatinine, Anxiety, depression and stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200322046834N1
Registration date: 2020-04-23, 1399/02/04
Registration timing: prospective

Last update: 2020-04-23, 1399/02/04
Update count: 0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
Faezeh Darabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 2107
Email address
faeze.darabi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of E & C vitamins effects on oxidative stress biomarkers, biochemical parameters, Depression, anxiety and stress in workers exposed to noise, cement dust and silica in SHIRAZ cement plant.
Public title
Assessment of vitamin C and E effect in prevent of disease in workers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least 5 years job experience sign the written informed consent
Exclusion criteria:
Workers have underlying disease including diabetes, heart disease, kidney disease,gastrointestinal discomfort, and hypertension Using particular drug or vitamins that effect on our intervention
Age
From 20 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, because the cement plant consisted of different sections, We chose the stratified randomization method, In this study we have seven units in cement plant and With regard to the number of people in each section we chose our community to participate in this study.After stratified randomization and selection of the total sample size (80)select workers we use flip the coin method to choose participants for intervention and the group of vitamins intervention and placebo intervention will be determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study we will provide placebo tablet similar to the original tablets content C and E vitamins.Then vitamins and placebos will give to participants by assistant, researcher and participants will not aware of content of tablets.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
No. 11, Second Alley, Second 16 meters Street, Shahid Najafi Quarter, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6719683515
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.SUMS.REC.1398.386

Health conditions studied

1

Description of health condition studied
The participant of this study are workers who exposed to harmful agent include cement dust, silica, noise in cement plant
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Malondialdehyde
Timepoint
malondialdehyde measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Malondialdehyde will measure based on its reaction with thiobarbituric acid reactive substances and will determine by using fluorimetry.

2

Description
Total antioxidant capacity
Timepoint
Total antioxidant capacity measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Total antioxidant capacity will be measured by ferric reducing ability in plasma method.

3

Description
Superoxide dismutase
Timepoint
Superoxide dismutase measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Activity of superoxide dismutase will measure by superoxide dismutase kit.

4

Description
Catalase
Timepoint
Catalase measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Catalase enzyme will determine by catalase kit

5

Description
Alkaline phosphatase
Timepoint
Alkaline phosphatasemeasurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Alkaline phosphatase will be measured by using standard kit and auto analyzer system.

6

Description
Alanine transaminase
Timepoint
Alanine transaminasemeasurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
alanine transaminase will be measured by using standard kit and auto analyzer system.

7

Description
Aspartate transaminase
Timepoint
Aspartate transaminasemeasurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Aspartate transaminase will be measured by using standard kit and auto analyzer system.

8

Description
High density lipid
Timepoint
High density lipid measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
High density lipid will be measured by using standard kit and auto analyzer system.

9

Description
Low density lipid
Timepoint
Low density lipid measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Low density lipid will be measured by using standard kit and auto analyzer system.

10

Description
Triglyceride
Timepoint
Triglyceride measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Triglyceride will be measured by using standard kit and auto analyzer system.

11

Description
Total bilirubin
Timepoint
Total bilirubin measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Total bilirubin will be measured by using standard kit and auto analyzer system.

12

Description
Glucose
Timepoint
Glucose measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Glucose will be measured by using standard kit and auto analyzer system.

13

Description
Albumin
Timepoint
Albumin measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Albumin will be measured by using standard kit and auto analyzer system.

14

Description
Creatinine
Timepoint
Creatinine measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
creatinine will be measured by using standard kit and auto analyzer system.

15

Description
Cholesterol
Timepoint
Cholesterol measurement will be performed One day befor the intervention, And one day after the intervention.
Method of measurement
Cholesterol will be measured by using standard kit and auto analyzer system.

16

Description
Depression
Timepoint
The DASS-21 questionnaire will be filled by the participants one day befor intervention and one day after intervention.
Method of measurement
Participants' depression will be obtained by using the total score obtained from filling out the questions.

17

Description
Stress
Timepoint
The DASS-21 questionnaire will be filled by the participants one day befor intervention and one day after intervention
Method of measurement
Participants' stress will be obtained by using the total score obtained from filling out the questions.

18

Description
Anexiety
Timepoint
The DASS-21 questionnaire will be filled by the participants one day befor intervention and one day after intervention.
Method of measurement
Participants' anexity will be obtained by using the total score obtained from filling out the questions.

Secondary outcomes

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Intervention groups

1

Description
Intervention group: This group will 40 participants that use vitamin E and vitamin C, The does of them by arrangement are 400 IU and 500mg. They will use these vitamins for tow month and our assistant give its to them every day after lunch. these vitamins product by Dena Pharmaceutical Company.
Category
Prevention

2

Description
Control group: This group will 40 participants that use placepo for tow month and our assistant give its to them every day after lunch. The content of them is sugar. these placebos product by Dena Pharmaceutical Company.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fars cement bplant
Full name of responsible person
Alireza Bostanian
Street address
No. 45, Hedayat Street, Postchi Blvd
City
Shiraz
Province
Fars
Postal code
7134953884
Phone
+98 71 3822 8644
Email
faeze.darabi@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kamyar Zomorodian
Street address
school of health, front of the Bargh club, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134953884
Phone
+98 71 3235 1268
Email
faeze.darabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Faeze Darabi
Position
Student
Latest degree
Master
Other areas of specialty/work
Occupational Health
Street address
school of health, front of the Bargh club, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
6719683515
Phone
+98 83 3837 2107
Email
faeze.darabi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Faezeh Darabi
Position
Student
Latest degree
Master
Other areas of specialty/work
Occupational Health
Street address
No 45. Hedayat Street, Soratgar Blvd.
City
Shiraz
Province
Fars
Postal code
7134953884
Phone
+98 71 3235 1268
Email
faeze.darabi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Faezeh Darabi
Position
Master
Latest degree
Master
Other areas of specialty/work
Occupational Health
Street address
No. 11. Second Alley. Second 16 meters Street. Shahid Najafi Quarter. Kermanshah. Iran
City
Kermanshah
Province
Kermanshah
Postal code
6719683515
Phone
+98 83 3837 2107
Fax
Email
faeze.darabi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data about participants such as main variable can be share after unrecognizable our participants
When the data will become available and for how long
The time to accesses the information will be four month after publish the results
To whom data/document is available
The information will be available to researchers every where, And we will give the information to people who working in industry.
Under which criteria data/document could be used
After do statistical analyses on our information we publish the data in an article, So it will be available for every one.
From where data/document is obtainable
Individuals can access the article by searching the subjects name that we express, And the article will include the editors email address to answer questions.
What processes are involved for a request to access data/document
After publish the article editor will be online to answer your request, And the process of doing this project and publish article about it has need 8 month nearly
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