Protocol summary

Summary
This research to determine the effect of omega-3 and vitamin C in serum cortisol, CRP, TAC, MDA, IL-6 and depression score and the number of job errors in shift workers Tehran oil refinery Was designed. This study is a double-blind intervention study with a placebo control group and 2 months of intervention with omega-3[each capsule containing 180 mg EPA(eicosapantanoic acid) and 120 mg DHA(docosahezanoic acid)] and vitamin C(250mg ascorbic acid) alone and in combination on the above variables in rotational depressed shift worker in Tehran Refinery.In first Beck Depression Inventory and the general questioner in all workers at operational and firefighting sites(456 people) will be distributed. People have entry criteria and no exclusion criteria were enrolled into the study. Inclusion criteria depression score equal to or more than 10 of the 21 item questionnaire Beck (beck) was agree to participate in research out of the presence of disease (thyroid, kidney, liver, diabetes, heart Cardiovascular, cancer, hypertension) based on the contents of employment records of individuals, as a professional exercise, smoking, alcohol consumption, drug materials, drug, or over two weeks before the study and taking supplements and drugs for depression at 2 months ago of studyso 136 shift workers entered to intervention. Blood serum to measure these markers before and after intervention with 10-12 hours fasting in 7.30-8.30 the morning 8cc fasting blood can receive, 24 h food questionnaire data collected through interviews. be collected, diastolic blood pressure, weigh and high is measured to calculate BMI .During the study, subjects were asked not to change their diet. After explaining the study and how its implementation of all participants in the intervention, written consent was obtained for participation in research. For intervention research shift worker using a balanced block randomization method were divided into 4 groups. Omega-3 capsules and tablets appear to be different so, double-dummy technique was used in the study. In Group 1, 2 capsules omega-3 and 2 tablets of vitamin C and in Group 2, 2 capsules of omega-3 and 2 placebo tablet of vitamin C and group 3, 2 tablets of vitamin C and 2 placebo capsule of omega-3 in the group 4،2 placebo capsule of omega-3 and 2 placebo tablet of vitamin C for every day in 2 months. this study approved by Medical Ethics Medical School University took place in Tehran.

General information

Acronym
IL-6 Interleukin 6-CRP C-Reactive Protein -BMI Body Mass Index--ROS Reactive Oxygen Speci
IRCT registration information
IRCT registration number: IRCT201202189056N1
Registration date: 2012-06-05, 1391/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-05, 1391/03/16
Registrant information
Name
Syed Bagher Mortazavi
Name of organization / entity
Tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3825
Email address
mortazav@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2011-11-06, 1390/08/15
Expected recruitment end date
2012-04-03, 1391/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studies on the possibie lowering of occupational errors by intervention on inflammatory , oxidative stress factors and depression in Tehran refinery oil shift workers treated with omega 3 and vitaminC.
Public title
Studies on the possibie lowering of occupational errors by intervention on inflammatory , oxidative stress factors and depression in Tehran refinery oil shift workers treated with omega 3 and vitaminC.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: -- Willingness to cooperate with research - Their depression score is higher than others Exclusion criteria: - Liver disease, renal, cardiovascular and diabetes - Blood pressure drugs - Cigarettes and alcohol and drug - Taking vitamin supplements and omega - 3 - Taking antidepressant
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
for the first time

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Faculty of Medicin-Tarbiat Modares University- Near to Gisha bridge- Kargar shomali ave.Tehran
City
Tehran
Postal code
Approval date
2011-11-05, 1390/08/14
Ethics committee reference number
5321065

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.0 ,F32
ICD-10 code description
Mild and moderate depression

Primary outcomes

1

Description
Depression score
Timepoint
2 months
Method of measurement
Beck Depression Inventory

Secondary outcomes

1

Description
CORTISOL
Timepoint
2 months
Method of measurement
blood sample

2

Description
hs.CRP
Timepoint
2 months
Method of measurement
blood sample

3

Description
TAC
Timepoint
2 nonths
Method of measurement
blood sampling

4

Description
IL-6
Timepoint
2 months
Method of measurement
blood sampling

5

Description
MAD
Timepoint
2 months
Method of measurement
blood sampling

Intervention groups

1

Description
omega-3 1000mg(180 mg EPA and 120 mg DHA) vitamin C 250 mg every day 2 capsuls omega-3and 2 tablats vitamin C
Category
Treatment - Drugs

2

Description
omega-3 and placebo vitamin c
Category
Treatment - Drugs

3

Description
placebo omega-3 and vitamin C
Category
Treatment - Drugs

4

Description
placebo omega-3 and placebo vitamin c
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tondgooian Tehran oil refinery
Full name of responsible person
Dr. Seyed Bagher Mortazavi
Street address
Tarbiat Modares University- Near to Gisha bridge- Kargar shomali ave.Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mr. moosavian
Street address
Tarbiat Modares University- Near to Gisha bridge- Kargar shomali ave.Tehran
City
Tehran
Grant name
پشتیبانی از پایان نامه ها و رساله ها
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
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

Person responsible for general inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farahnaz Khajehnasiri
Position
PhD candidate
Other areas of specialty/work
Street address
Tarbiat Modares University- Near to Gisha bridge- Kargar shomali ave.Tehran
City
Tehran
Postal code
Phone
+98 21 8800 2520
Fax
+98 21 8288 3825
Email
f.khajenasiri@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Seyed Bagher Mortazavi
Position
Associate professor
Other areas of specialty/work
Street address
Tarbiat Modares University- Near to Gisha bridge- Kargar shomali ave.Tehran
City
Tehran
Postal code
Phone
+98 21 8288 3825
Fax
+98 21 8288 3825
Email
mortazav@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farahnaz Khajehnasiri
Position
PhD candidate
Other areas of specialty/work
Street address
Tarbiat Modares University- Near to Gisha bridge- Kargar shomali ave.Tehran
City
Tehran
Postal code
Phone
+98 21 8288 3825
Fax
Email
f.khajenasiri@modares.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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