Effects of using vitamins E and C in reducing Extremely Low-Frequency Electromagnetic Fields adverse health effects

• Register: IRCT
• Last refreshed on: 14 January 2019
• Main ID: IRCT2016020926466N1
• Date of registration: 2017-02-28
• Prospective Registration: Yes
• Primary sponsor: Shahroud University of Medical Sciences
• Public title: Effects of using vitamins E and C in reducing Extremely Low-Frequency Electromagnetic Fields adverse health effects
• 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
• Date of first enrolment: 2017-06-04
• Target sample size: 95
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/21935
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: Randomization assignment will be done by permuted blocked method into four groups using computer-generated random numbers. The allocation will be concealed from participants, Blinding description: The study will be double-blind. Data analyzer, participants, and outcome assessor won't be informed of allocation.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Mehdi Mirzaii
• Affiliation: Shahroud University of Medical Sciences

• Name: Majid Bagheri Hossein Abadi
• Affiliation: Shahroud University of Medical Sciences

Key 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: 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

Age minimum: 20 years
Age maximum: 50 years
Gender: Male

Health Condition(s) or Problem(s) studied

Oxidative stress, DNA damage, Apoptosis, Pre-inflammatory cytokines.

Intervention(s)

Intervention 1: Vitamin E, 400 IU oral tablet, once a day for three months. Intervention 2: Vitamin C, 1000 mg oral tablet, once a day for three months. Intervention 3: Vitamins E and C, 400 IU and 1000 mg oral tablet, once a day for three months. Intervention 4: There will be no intervention.

Primary Outcome(s)

DNA damage index. Timepoint: Before and after intervention. Method of measurement: Comet Assay.

Apoptosis. Timepoint: Before and after intervention. Method of measurement: Flow cytometry.

Serum level of interleukin 6. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Serum level of superoxide dismutase. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Serum level of glutathione. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Serum level of interleukin-1 beta. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Serum level of total antioxidant capacity. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Serum level of catalase. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Serum level of tumor necrosis factor alpha. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Serum level of ceruloplasmin. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Serum level of malondialdehyde. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Secondary Outcome(s)

Glucose. Timepoint: Before and after intervention. Method of measurement: Enzymatic-colorimetric at 546 nm wavelength.

Aspartate transaminase. Timepoint: Before and after intervention. Method of measurement: Colorimetric at 340 nm wavelength.

Alanine transaminase. Timepoint: Before and after intervention. Method of measurement: Colorimetric at 570 nm wavelength.

Calcium. Timepoint: Before and after intervention. Method of measurement: Arsenoza.

Cholesterol. Timepoint: Before and after intervention. Method of measurement: Enzymatic-colorimetric at 546 nm wavelength.

Uric acid. Timepoint: Before and after intervention. Method of measurement: Enzymatic-colorimetric at 520 nm wavelength.

Vitamin D. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).

Albumin. Timepoint: Before and after intervention. Method of measurement: Bromocresol green.

Triglycerides. Timepoint: Before and after intervention. Method of measurement: Enzymatic-colorimetric at 510 nm wavelength.

Complete blood count. Timepoint: Before and after intervention. Method of measurement: By Cell Counter.

Urea. Timepoint: Before and after intervention. Method of measurement: UV test.

High sensitivity C-reactive protein. Timepoint: Before and after intervention. Method of measurement: Immunoturb.

Creatinine. Timepoint: Before and after intervention. Method of measurement: Jaffe.

High-density lipoprotein. Timepoint: Before and after intervention. Method of measurement: Immunoinhibition.

Low-density lipoprotein. Timepoint: Before and after intervention. Method of measurement: Direct method.

Phosphorous. Timepoint: Before and after intervention. Method of measurement: U.V test.

Total protein. Timepoint: Before and after intervention. Method of measurement: Biuret.

Source(s) of Monetary Support

Shahroud University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Shahroud University of Medical Sciences