History
# Registration date Revision Id
2 2018-12-02, 1397/09/11 70386
1 2017-02-28, 1395/12/10 21935
Changes made to previous revision
This is the first revision

Protocol summary

Summary
The present study aimed at determining the effect of exposure to Extremely Low Frequency Electromagnetic Fields (ELF-EMFs) on oxidative stress and feasibility using of vitamins E and C as a treatment solution in order to reduce the effects of oxidative stress. The design of this study is Randomized double-blind study, non-placebo control and single-center. The population will be Shaheed Bastami power plant’s employees who directly exposed to ELF-EMFs of high voltage lines. The inclusion criteria are having at least one year of experience, working full time at the power plant and the range of age is 20 to 50 years of age. The exclusion Criteria are the people with hypertension according to WHO, haven’t treated by antioxidant dietary supplements and drugs with antioxidant properties and not using vitamins and antioxidants, such as vitamin E, C and beta-carotene and selenium. Sample size is 95 of Shaheed Bastami power plant’s employees. The people randomly divided into equal four groups in two stages based on block randomization. First group a tablet vitamin E 400 IU/day, second group a tablet vitamin C 1000 mg/day, third group a tablet containing vitamin E and C, 400 IU/day and 1000 mg/day respectively and forth group non-intervention during three months. Main outcomes are oxidative stress including Malondialdehyde, Superoxide dismutase, Catalase, Glutathione, Ceruloplasmin and Total Antioxidant Capacity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020926466N1
Registration date: 2017-02-28, 1395/12/10
Registration timing: prospective

Last update:
Update count: 1
Registration date
2017-02-28, 1395/12/10
Registrant information
Name
Majid Bagheri Hossein Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3236 1718
Email address
m.bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The study has founded by Shahroud university of Medical Sciences
Expected recruitment start date
2017-06-04, 1396/03/14
Expected recruitment end date
2017-10-21, 1396/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Extremely Low Frequency Electromagnetic Fields Effects on Oxidative Stress and Reducing the effects of Oxidative Stress by Intervention of Vitamin E and C in Shaheed Bastami Power Plant’s Workers; A Duble Blind, Randomized Clinical Trial Study; 2017
Public title
Survey of using vitamin E and C on reduction of Extremely Low Frequency Electromagnetic Fields harmful effects
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: At least one year of experience at the power plant; Working full time at the power plant; In the range of 20 to 50 years of age. Exclusion Criteria: Person with hypertension according to WHO; Not treated antioxidant dietary supplements; No drugs have antioxidant properties; Not using vitamins and antioxidants, such as vitamin E, C and beta-carotene and selenium.
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 95
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Hafte-Tir square, Shahrood University of Medical Sciences
City
Shahroud
Postal code
3614773955
Approval date
2016-09-10, 1395/06/20
Ethics committee reference number
IR.SHMU.1395.94

Health conditions studied

1

Description of health condition studied
Oxidative Stress
ICD-10 code
Z10.0
ICD-10 code description
Occupational health examination

Primary outcomes

1

Description
Malondialdehyde
Timepoint
Before and after intervention
Method of measurement
colorimetric (532 nm)/fluorometric

2

Description
Superoxide dismutase
Timepoint
Before and after intervention
Method of measurement
colorimetric (420nm)/fluorometric

3

Description
Catalase
Timepoint
Before and after intervention
Method of measurement
colorimetric (405nm)/fluorometric

4

Description
Glutathione
Timepoint
Before and after intervention
Method of measurement
colorimetric (412nm)

5

Description
Ceruloplasmin
Timepoint
Before and after intervention
Method of measurement
colorimetric (560nm)

6

Description
Total Antioxidant Capacity
Timepoint
Before and after intervention
Method of measurement
colorimetric (570nm)

Secondary outcomes

1

Description
CHOLESTEROL
Timepoint
Before and after Intervention
Method of measurement
CHOD-PAP

2

Description
CBC
Timepoint
Before and after Intervention
Method of measurement
by Cell Counter

3

Description
HDL
Timepoint
Before and after Intervention
Method of measurement
HDL-C

4

Description
LDL
Timepoint
Before and after Intervention
Method of measurement
LDL-C

5

Description
SGPT
Timepoint
Before and after Intervention
Method of measurement
IFCC

6

Description
SGOT
Timepoint
Before and after Intervention
Method of measurement
IFCC

7

Description
CREATININE
Timepoint
Before and after Intervention
Method of measurement
JAFFE

8

Description
Urea
Timepoint
Before and after Intervention
Method of measurement
UV-TEST

9

Description
URIC ACID
Timepoint
Before and after Intervention
Method of measurement
PAP

10

Description
TRIGLYCERIDES
Timepoint
Before and after Intervention
Method of measurement
GPO-PAP

11

Description
GLUCOSE
Timepoint
Before and after Intervention
Method of measurement
GOD-PAP

Intervention groups

1

Description
Vitamin E, 400 IU oral tablet, once a day for three months
Category
Prevention

2

Description
Vitamin C, 1000 mg oral tablet, once a day for three months
Category
Prevention

3

Description
Vitamins E and C, 400 IU and 1000 mg oral tablet, once a day for three months
Category
Prevention

4

Description
did not any intervention in the control group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahroud University of Medical Sciences
Full name of responsible person
Majid Bagheri Hossein Abadi and Pirasteh Norouzi
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
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
Shahroud University of Medical Sciences
Full name of responsible person
Majid Bagheri Hossein Abadi
Position
Post Graduate of Occupational Health Engineering
Other areas of specialty/work
Street address
Hafte-Tir square, Shahroud University of Medical Sciences
City
Shahrood
Postal code
3614773955
Phone
+98 23 3236 1718
Fax
Email
m.bagheri@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mehdi Mirzaii
Position
Microbiology
Other areas of specialty/work
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Postal code
3617753917
Phone
+98 23 3236 4499
Fax
Email
mirzaii1386@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Majid Bagheri Hossein Abadi
Position
Post Graduate of Occupational Health Engineering
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte tir Square
City
Shahroud
Postal code
Phone
+98 23 3236 1718
Fax
Email
m.bagheri@shmu.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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