Protocol summary
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Study aim
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The aim of this study will be to determine the effect of exposure to Extremely Low-Frequency Electromagnetic Fields (ELF-EMFs) on oxidative stress and also the feasibility of using vitamins E and C as a therapeutic solution in order to reduce the effects of oxidative stress.
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Design
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A controlled, double-blinded, permuted block randomization clinical trial among 96 power plant workers for 3 months.
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Settings and conduct
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The workers who are working in the different sections of the power plant will be divided into four groups, and group 1 will receive 400 IU vitamin E, group 2 will receive 1000 mg vitamin C, group C will receive 400 IU vitamin E and 1000 mg vitamin C, and group 4 will not receive any intervention. The data collectors will be blinded through coded participants.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: in the range of 20 to 50 years of age, working full time at the power plant and at least one year of experience at the power plant.
Exclusion criteria: renal disorders, hypertension and using drugs and dietary supplementary with antioxidant properties.
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Intervention groups
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Group 1: 400 IU vitamin E;
Group 2: 1000 mg vitamin C;
Group 3: 400 IU vitamin E and 1000 mg vitamin C;
Group 4: the control group does not receive the intervention.
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Main outcome variables
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Malondialdehyde; Superoxide dismutase; Catalase; Glutathione; Ceruloplasmin; Total Antioxidant Capacity; DNA damage; apoptosis; Interleukin 6; Interleukin 1b; Tumor necrosis factor alpha; The level of extremely low frequency electromagnetic fields exposure
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016020926466N1
Registration date:
2017-02-28, 1395/12/10
Registration timing:
prospective
Last update:
2018-12-12, 1397/09/21
Update count:
1
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Registration date
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2017-02-28, 1395/12/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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The study has founded by Shahroud university of Medical Sciences
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Expected recruitment start date
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2017-06-04, 1396/03/14
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Expected recruitment end date
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2017-10-21, 1396/07/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effects of using vitamins E and C in reducing Extremely Low-Frequency Electromagnetic Fields adverse health effects
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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:
Hypertension according to WHO's definition
Using antioxidant dietary supplements
Using drugs with antioxidant properties
Using vitamins and antioxidants, such as vitamin E, C and beta-carotene and selenium
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Age
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From 20 years old to 50 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
95
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization assignment will be done by permuted blocked method into four groups using computer-generated random numbers. The allocation will be concealed from participants.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The study will be double-blind. Data analyzer, participants, and outcome assessor won't be informed of allocation
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Placebo
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Used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-09-10, 1395/06/20
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Ethics committee reference number
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IR.SHMU.1395.94
Health conditions studied
1
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Description of health condition studied
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Oxidative stress, DNA damage, Apoptosis, Pre-inflammatory cytokines
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Serum level of malondialdehyde
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
2
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Description
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Serum level of superoxide dismutase
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
3
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Description
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Serum level of catalase
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
4
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Description
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Serum level of glutathione
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
5
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Description
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Serum level of ceruloplasmin
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
6
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Description
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Serum level of total antioxidant capacity
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
7
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Description
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DNA damage index
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Timepoint
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Before and after intervention
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Method of measurement
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Comet Assay
8
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Description
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Apoptosis
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Timepoint
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Before and after intervention
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Method of measurement
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Flow cytometry
9
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Description
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Serum level of interleukin 6
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
10
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Description
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Serum level of interleukin-1 beta
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
11
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Description
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Serum level of tumor necrosis factor alpha
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
Secondary outcomes
1
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Description
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Cholesterol
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Timepoint
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Before and after intervention
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Method of measurement
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Enzymatic-colorimetric at 546 nm wavelength
2
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Description
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Complete blood count
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Timepoint
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Before and after intervention
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Method of measurement
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By Cell Counter
3
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Description
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High-density lipoprotein
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Timepoint
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Before and after intervention
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Method of measurement
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Immunoinhibition
4
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Description
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Low-density lipoprotein
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Timepoint
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Before and after intervention
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Method of measurement
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Direct method
5
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Description
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Alanine transaminase
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Timepoint
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Before and after intervention
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Method of measurement
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Colorimetric at 570 nm wavelength
6
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Description
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Aspartate transaminase
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Timepoint
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Before and after intervention
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Method of measurement
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Colorimetric at 340 nm wavelength
7
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Description
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Creatinine
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Timepoint
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Before and after intervention
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Method of measurement
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Jaffe
8
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Description
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Urea
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Timepoint
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Before and after intervention
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Method of measurement
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UV test
9
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Description
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Uric acid
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Timepoint
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Before and after intervention
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Method of measurement
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Enzymatic-colorimetric at 520 nm wavelength
10
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Description
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Triglycerides
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Timepoint
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Before and after intervention
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Method of measurement
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Enzymatic-colorimetric at 510 nm wavelength
11
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Description
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Glucose
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Timepoint
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Before and after intervention
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Method of measurement
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Enzymatic-colorimetric at 546 nm wavelength
12
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Description
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Total protein
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Timepoint
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Before and after intervention
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Method of measurement
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Biuret
13
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Description
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Albumin
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Timepoint
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Before and after intervention
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Method of measurement
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Bromocresol green
14
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Description
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Vitamin D
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Timepoint
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Before and after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA)
15
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Description
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Calcium
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Timepoint
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Before and after intervention
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Method of measurement
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Arsenoza
16
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Description
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Phosphorous
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Timepoint
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Before and after intervention
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Method of measurement
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U.V test
17
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Description
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High sensitivity C-reactive protein
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Timepoint
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Before and after intervention
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Method of measurement
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Immunoturb
Intervention groups
1
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Description
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Vitamin E, 400 IU oral tablet, once a day for three months
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Category
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Prevention
2
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Description
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Vitamin C, 1000 mg oral tablet, once a day for three months
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Category
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Prevention
3
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Description
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Vitamins E and C, 400 IU and 1000 mg oral tablet, once a day for three months
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Category
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Prevention
4
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Description
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There will be no intervention
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahroud University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Oxidative stress, DNA damage, Apoptosis, and pro-inflammatory cytokines
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Scientific researchers
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Under which criteria data/document could be used
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Without any condition
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From where data/document is obtainable
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Vice Chancellor for Research, Shahroud University of medical sciences
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What processes are involved for a request to access data/document
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By sending a request email
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Comments
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