History
# Registration date Revision Id
2 2018-12-02, 1397/09/11 70386
1 2017-02-28, 1395/12/10 21935
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  • Protocol 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.
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    هدف از مطالعه حاضر بررسی رابطه بین میزان مواجهه با امواج الکترومغناطیس با طول موج فوق العاده کوتاه (ELF-EMFs) و استرس اکسیداتیو و همچنین امکان سنجی استفاده از ویتامین های E و C به عنوان راه حل درمانی در جهت کاهش اثرات استرس اکسیداتیو است. طراحی این مطالعه به صورت تصادفی، دو سویه کور، کنترل بدون دارونما و تک مرکزی است. این مطالعه بر روی کارکنان نیروگاه برق که در مواجهه مستقیم با ELF-EMFs ناشی از خطوط پرفشار جریان برق هستند انجام خواهد شد. معیارهای ورود شامل سابقه کار حداقل یک سال و کار تمام وقت در نیروگاه است. علاوه بر این معیارهای خروج شامل عدم ابتلا به پرفشار خون مطابق با WHO، عدم استفاده از مکمل ها، غذاها و داروهای آنتی اکسیدانی است. حجم نمونه شامل 95 نفر از کارکنان واحدهای عملیاتی نیروگاه برق خواهد بود. افراد براساس تخصیص تصادفی بلوکه بندی شده در طی دو مرحله به چهار گروه مساوی تقسیم می شوند. گروه اول 400 واحد بین المللی ویتامین E در روز، گروه دوم 1000 میلی گرم ویتامین C در روز، گروه سوم 1000 میلی گرم ویتامین C در روز و 400 واحد بین المللی ویتامین E در روز و گروه کنترل بدون دریافت هیچگونه ویتامین درمان می شوند. طول دوره درمان به مدت 3 ماه (90 روز) و دوز تجویز شده با مقادیر ذکر شده و در طی 7 روز هفته مصرف می شود. استرس اکسیداتیو شامل ملان دی آلدهید، سوپر اکسید دیسموتاز، کاتالاز، گلوتاتیون، سرولوپلاسمین و ظرفیت اکسیدانی تام قبل از مداخله و بعد از مداخله اندازه گیری خواهد شد.
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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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    هدف از مطالعه حاضر تعیین رابطه بین میزان مواجهه با امواج الکترومغناطیس با طول موج فوق العاده کوتاه (ELF-EMFs) بر استرس اکسیداتیو و همچنین امکان سنجی استفاده از ویتامین های E و C به عنوان راه حل درمانی در جهت کاهش اثرات استرس اکسیداتیو خواهد بود.
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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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    یک کارآزمایی بالینی دارای گروه کنترل، دو سویه کور ، تصادفی شده بلوکه ای در میان 96 نفر از کارکنان نیروگاه برق برای 3 ماه.
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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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    کارکنان شاغل در بخش های مختلف نیروگاه برق به چهار گروه تقسیم شده و گروه اول 400 واحد ویتامین E، گروه دوم 1000 میلی گرم ویتامین C، گروه سوم 400 واحد ویتامین E و 1000 میلی گرم ویتامین C دریافت می کنند و گروه چهارم هیچ مداخله ای دریافت نمی کند. جمع آوری کننده های اطلاعات از طریق افراد شرکت کننده کدگذاری شده کورسازی می شود.
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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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    معیارهای ورود: سن فرد در محدوده 20 تا 50 سال، کار تمام وقت در نیروگاه و حداقل دو سال سابقه کار در نیروگاه. شرایط عدم ورود: بیماری کلیوی، فشار خون بالا و استفاده از داورها و مکمل های غذایی دارای خاصیت آنتی اکسیدانی.
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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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    گروه اول: 400 واحد بین المللی ویتامین E؛ گروه دوم: 1000 میلی گرم ویتامین C؛ گروه سوم: 400 واحد بیم المللی ویتامی E و 1000 میلی گرم ویتامین C؛ گروه چهارم: گروه کنترل مداخله ای دریافت نمی کند؛
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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
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    ملان دی آلدهید؛ سوپر اکسید دیسموتاز؛ کاتالاز؛ گلوتاتیون؛ سرولوپلاسمین؛ ظرفیت اکسیدانی تام؛ آسیب DNA؛ آپاپتوز؛ اینترلوکین 6؛ اینترلوکین 1 بتا؛ فاکتور نکروز توموری آلفا؛ سطح مواجهه با میدان های الکترومغناطیس با فرکانس فوق العاده کوتاه
  • General information

    1
    1
    1
    1
    Not used
    Used
    Survey of using vitamin E and C on reduction of Extremely Low Frequency Electromagnetic Fields harmful effects
    Effects of using vitamins E and C in reducing Extremely Low-Frequency Electromagnetic Fields adverse health effects
    بررسی استفاده از ویتامین E و C در کاهش اثرات زیان آور امواج الکترومغناطیس با فرکانس فوق العاد کوتاه
    اثرات استفاده از ویتامین E و C در کاهش اثرات زیان آور سلامتی امواج الکترومغناطیس با فرکانس فوق العاد کوتاه
    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
    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
    بررسی اثرات امواج الکترومغناطیس با فرکانس فوق العاد کوتاه بر استرس اکسیداتیو و مداخله با ویتامین E و C برای کاهش اثرات استرس اکسیداتیو در کارکنان نیروگاه برق شهید بسطامی شاهرود؛ یک مطالعه کارآزمایی بالینی تصادفی شده دو سو کور 1396
    بررسی اثرات امواج الکترومغناطیس با فرکانس فوق العاد کوتاه بر استرس اکسیداتیو و مداخله با ویتامین E و C برای کاهش اثرات استرس اکسیداتیو در کارکنان نیروگاه برق شهید بسطامی شاهرود؛ یک مطالعه کارآزمایی بالینی تصادفی شده دو سو کور
    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
    حداقل یکسال سابقه کار در نیروگاه
    کار تمام وقت در نیروگاه
    سن فرد در محدوده 20 تا 50 سال
    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
    ابتلا به فشار خون براساس تعریف WHO
    استفاده از مکمل های غذایی آنتی اکسیدانی
    مصرف داروهای دارای خواص آنتی اکسیدانی
    استفاده از ویتامین ها و مواد آنتی اکسیدانی شامل ویتامین E، C و بتاکاروتن و سلنیوم
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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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    تخصیص تصادفی با روش بلوکه ای به گروه های چهارتایی با استفاده از تولید اعداد تصادفی کامپیوتری انجام خواهد شد. تخصیص از افراد شرکت کننده پنهان سازی می شود.
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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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    مطالعه به صورت دو سو کور خواهد بود. آنالیز کننده داده، شرکت کنندگان، و ارزیابی کننده پیامد از قرار گیری فرد در گروه ها مطلع نخواهند شد
  • Health conditions studied

    #1
    Z10.0
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    Occupational health examination
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    Oxidative Stress
    Oxidative stress, DNA damage, Apoptosis, Pre-inflammatory cytokines
    استرس اکسیداتیو
    استرس اکسیداتیو، آسیب DNA، آپاپتوز و سیتوکین های پیش التهابی
  • Primary outcomes

    #1
    Malondialdehyde
    Serum level of malondialdehyde
    مالون دی آلدهید
    سطح سرمی مالون دی آلدهید
    قبل از مداخله و بعد از مداخله
    قبل و بعد از مداخله
    colorimetric (532 nm)/fluorometric
    Enzyme-linked immunosorbent assay (ELISA)
    روش رنگ سنجی و در طول موج 530 نانومتر
    روش الایزا
    #2
    Superoxide dismutase
    Serum level of superoxide dismutase
    سوپراکسید دیسموتاز
    سطح سرمی سوپراکسید دیسموتاز
    قبل از مداخله و بعد از مداخله
    قبل و بعد از مداخله
    colorimetric (420nm)/fluorometric
    Enzyme-linked immunosorbent assay (ELISA)
    روش رنگ سنجی و در طول موج 420 نانومتر
    روش الایزا
    #3
    Catalase
    Serum level of catalase
    کاتالاز
    سطح سرمی کاتالاز
    قبل از مداخله و بعد از مداخله
    قبل و بعد از مداخله
    colorimetric (405nm)/fluorometric
    Enzyme-linked immunosorbent assay (ELISA)
    روش رنگ سنجی و در طول موج 405 نانومتر
    روش الایزا
    #4
    Glutathione
    Serum level of glutathione
    گلوتاتیون
    سطح سرمی گلوتاتیون
    قبل از مداخله و بعد از مداخله
    قبل و بعد از مداخله
    colorimetric (412nm)
    Enzyme-linked immunosorbent assay (ELISA)
    روش رنگ سنجی
    روش الایزا
    #5
    Ceruloplasmin
    Serum level of ceruloplasmin
    سرولوپلاسمین
    سطح سرمی سرولوپلاسمین
    قبل از مداخله و بعد از مداخله
    قبل و بعد از مداخله
    colorimetric (560nm)
    Enzyme-linked immunosorbent assay (ELISA)
    روش رنگ سنجی
    روش الایزا
    #6
    Total Antioxidant Capacity
    Serum level of total antioxidant capacity
    ظرفیت اکسیدانی تام
    سطح سرمی ظرفیت اکسیدانی تام
    قبل از مداخله و بعد از مداخله
    قبل و بعد از مداخله
    colorimetric (570nm)
    Enzyme-linked immunosorbent assay (ELISA)
    روش رنگ سنجی
    روش الایزا
    #7
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    DNA damage index
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    شاخص آسیب DNA
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    Before and after intervention
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    قبل و بعد از مداخله
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    Comet Assay
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    کامت اسی
    #8
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    Apoptosis
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    آپاپتوز
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    Before and after intervention
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    قبل و بعد از مداخله
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    Flow cytometry
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    فلوسایتومتری
    #9
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    Serum level of interleukin 6
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    سطح سرمی اینترلوکین 6
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    Before and after intervention
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    قبل و بعد از مداخله
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    Enzyme-linked immunosorbent assay (ELISA)
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    روش الایزا
    #10
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    Serum level of interleukin-1 beta
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    سطح سرمی اینترلوکین 1 بتا
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    Before and after intervention
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    قبل و بعد از مداخله
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    Enzyme-linked immunosorbent assay (ELISA)
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    روش الایزا
    #11
    empty
    Serum level of tumor necrosis factor alpha
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    سطح سرمی فاکتور نکروز توموری آلفا
    empty
    Before and after intervention
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    قبل و بعد از مداخله
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    Enzyme-linked immunosorbent assay (ELISA)
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    روش الایزا
  • Secondary outcomes

    #1
    CHOLESTEROL
    Cholesterol
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    CHOD-PAP
    Enzymatic-colorimetric at 546 nm wavelength
    CHOD-PAP
    آنزیمی-کالریمتری در طول موج 546 نانومتر
    #2
    CBC
    Complete blood count
    CBC
    شمارش کامل خون
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    by Cell Counter
    By Cell Counter
    #3
    HDL
    High-density lipoprotein
    HDL
    لیپوپروتئین با چگالی بالا
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    HDL-C
    Immunoinhibition
    HDL-C
    مهار آنزیمی
    #4
    LDL
    Low-density lipoprotein
    LDL
    لیپوپروتئین‌ با چگالی کم
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    LDL-C
    Direct method
    LDL-C
    قرائت مستقیم
    #5
    SGPT
    Alanine transaminase
    SGPT
    آلانین آمینوترانسفراز
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    IFCC
    Colorimetric at 570 nm wavelength
    IFCC
    کالریمتری در طول موج 570 نانومتر
    #6
    SGOT
    Aspartate transaminase
    SGOT
    آسپارتات ترانس‌آمیناز
    Before and after Intervention
    Before and after intervention
    IFCC
    Colorimetric at 340 nm wavelength
    IFCC
    کالریمتری در طول موج 340 نانومتر
    #7
    CREATININE
    Creatinine
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    JAFFE
    Jaffe
    JAFFE
    ژافه
    #8
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    UV-TEST
    UV test
    UV-TEST
    آزمایش یو وی
    #9
    URIC ACID
    Uric acid
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    PAP
    Enzymatic-colorimetric at 520 nm wavelength
    PAP
    آنزیمی-کالریمتری در طول موج 520 نانومتر
    #10
    TRIGLYCERIDES
    Triglycerides
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    GPO-PAP
    Enzymatic-colorimetric at 510 nm wavelength
    GPO-PAP
    آنزیمی-کالریمتری در طول موج 510 نانومتر
    #11
    GLUCOSE
    Glucose
    Before and after Intervention
    Before and after intervention
    قبل از مداخله و پس از مداخله
    قبل و پس از مداخله
    GOD-PAP
    Enzymatic-colorimetric at 546 nm wavelength
    GOD-PAP
    آنزيمی-كالريمتری در طول موج 546 نانومتر
    #12
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    Total protein
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    پرتئین تام
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    Before and after intervention
    empty
    قبل و پس از مداخله
    empty
    Biuret
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    روش بیورت
    #13
    empty
    Albumin
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    آلبومین
    empty
    Before and after intervention
    empty
    قبل و بعد از مداخله
    empty
    Bromocresol green
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    بروموکروزول گرین
    #14
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    Vitamin D
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    ویتامین D
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    Before and after intervention
    empty
    قبل و بعد از مداخله
    empty
    Enzyme-linked immunosorbent assay (ELISA)
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    روش الیزا
    #15
    empty
    Calcium
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    کلسیم
    empty
    Before and after intervention
    empty
    قبل و بعد از مداخله
    empty
    Arsenoza
    empty
    روش آرسنوزا
    #16
    empty
    Phosphorous
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    فسفر
    empty
    Before and after intervention
    empty
    قبل و بعد از مداخله
    empty
    U.V test
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    روش یو وی
    #17
    empty
    High sensitivity C-reactive protein
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    پروتئین واکنشی سی با حساسیت بالا
    empty
    Before and after intervention
    empty
    قبل و بعد از مداخله
    empty
    Immunoturb
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    روش ایمنوتورب
  • Intervention groups

    #1
    did not any intervention in the control group.
    There will be no intervention
    هیچگونه مداخله ای نمی شود.
    هیچگونه مداخله ای نخواهد بود.
  • Recruitment centers

    #1
    Name of recruitment center - English: Shahroud University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی شاهرود
    Full name of responsible person - English: Majid Bagheri Hossein Abadi and Pirasteh Norouzi
    Full name of responsible person - Persian: مجید باقری حسین آبادی و پیراسته نوروزی
    Street address - English: Hafte-Tir Square, Shahroud University of Medical Sciences
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود، دانشکده پزشکی
    City - English: Shahroud
    City - Persian: شاهرود
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Shahroud University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی شاهرود
    Full name of responsible person - English: Majid Bagheri Hossein Abadi and Pirasteh Norouzi
    Full name of responsible person - Persian: مجید باقری حسین آبادی و پیراسته نوروزی
    Street address - English: Hafte-Tir Square, Shahroud University of Medical Sciences
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود، دانشکده پزشکی
    City - English: Shahroud
    City - Persian: شاهرود
    Province: Semnan
    Country: Iran (Islamic Republic of)
    Postal code: 3617753917
    Phone: +98 23 3236 4499
    Fax:
    Email: m.bagheri@shmu.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Shahroud University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شاهرود
    Full name of responsible person - English: Dr. Mohammad-Hassan Emamian
    Full name of responsible person - Persian: دکتر محمدحسن امامیان
    Street address - English: Hafte-Tir Square, Shahroud University of Medical Sciences
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
    City - English: Shahroud
    City - Persian: شاهرود
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Mohammad-Hassan Emamian
    Full name of responsible person - Persian: دکتر محمدحسن امامیان
    Street address - English: Hafte-Tir Square, Shahroud University of Medical Sciences
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
    City - English: Shahroud
    City - Persian: شاهرود
    Province: Semnan
    Country: Iran (Islamic Republic of)
    Postal code: 3617753917
    Phone: +98 23 3239 5054
    Fax:
    Email: emamian@shmu.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شاهرود
    دانشگاه علوم پزشکی شاهرود
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Shahroud University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود
    Full name of responsible person - English: Majid Bagheri Hossein Abadi
    Full name of responsible person - Persian: مجید باقری حسین آبادی
    Position - English: Post Graduate of Occupational Health Engineering
    Position - Persian: کارشناسی ارشد مهندسی بهداشت حرفه ای
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hafte-Tir square, Shahroud University of Medical Sciences
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
    City - English: Shahrood
    City - Persian: شاهرود
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3614773955
    Phone: +98 23 3236 1718
    Mobile: +98 912 943 0588
    Fax:
    Email: m.bagheri@shmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Majid Bagheri Hossein Abadi
    Full name of responsible person - Persian: مجید باقری حسین آبادی
    Position - English: Consultant
    Position - Persian: مشاور تحقیقاتی
    Latest degree: master
    Area of specialty/work: 80
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hafte-Tir square, Shahroud University of Medical Sciences
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
    City - English: Shahrood
    City - Persian: شاهرود
    Province: Semnan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3614773955
    Phone: +98 23 3236 1718
    Mobile: +98 912 943 0588
    Fax:
    Email: m.bagheri@shmu.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Shahroud University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود
    Full name of responsible person - English: Mehdi Mirzaii
    Full name of responsible person - Persian: مهدی میرزایی
    Position - English: Microbiology
    Position - Persian: دکتری تخصصی میکروبیولوژی (استادیار)
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hafte-Tir Square, Shahroud University of Medical Sciences
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
    City - English: Shahroud
    City - Persian: شاهرود
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3617753917
    Phone: +98 23 3236 4499
    Mobile: +98 912 573 6308
    Fax:
    Email: mirzaii1386@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mehdi Mirzaii
    Full name of responsible person - Persian: مهدی میرزایی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English: Medical Bacteriology
    Area of specialty/work title - Persian: باکتری شناسی پزشکی
    Street address - English: Hafte-Tir Square, Shahroud University of Medical Sciences
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
    City - English: Shahroud
    City - Persian: شاهرود
    Province: Semnan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3617753917
    Phone: +98 23 3236 4499
    Mobile: +98 912 573 6308
    Fax:
    Email: mirzaii1386@gmail.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Shahroud University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود
    Full name of responsible person - English: Majid Bagheri Hossein Abadi
    Full name of responsible person - Persian: مجید باقری حسین آبادی
    Position - English: Post Graduate of Occupational Health Engineering
    Position - Persian: کارشناسی ارشد مهندسی بهداشت حرفه ای
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahroud University of Medical Sciences, Hafte tir Square
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
    City - English: Shahroud
    City - Persian: شاهرود
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 23 3236 1718
    Mobile: +98 912 943 0588
    Fax:
    Email: m.bagheri@shmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Majid Bagheri Hossein Abadi
    Full name of responsible person - Persian: مجید باقری حسین آبادی
    Position - English: Consultant
    Position - Persian: مشاور تحقیقاتی
    Latest degree: master
    Area of specialty/work: 80
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahroud University of Medical Sciences, Hafte tir Square
    Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
    City - English: Shahroud
    City - Persian: شاهرود
    Province: Semnan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3614773955
    Phone: +98 23 3236 1718
    Mobile: +98 912 943 0588
    Fax:
    Email: m.bagheri@shmu.ac.ir
    Web page address:
  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    Oxidative stress, DNA damage, Apoptosis, and pro-inflammatory cytokines
    empty
    استرس اکسیداتیو، آسیب DNA، آپاپتوز و سیتوکین های پیش التهابی
    empty
    After publishing the article
    empty
    بعد از انتشار مقاله
    empty
    Scientific researchers
    empty
    محققین علمی
    empty
    Without any condition
    empty
    بدون هیچ شراطی
    empty
    Vice Chancellor for Research, Shahroud University of medical sciences
    empty
    معاونت پژوهشی، دانشگاه علوم پزشکی شاهرود
    empty
    By sending a request email
    empty
    از طریق ارسال یک ایمیل درخواست

Protocol summary

Study aim
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.
Design
A controlled, double-blinded, permuted block randomization clinical trial among 96 power plant workers for 3 months.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
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

Reason for update
Acronym
IRCT registration information
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
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
Public title
Effects of using vitamins E and C in reducing Extremely Low-Frequency Electromagnetic Fields adverse health 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:
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
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 95
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
The study will be double-blind. Data analyzer, participants, and outcome assessor won't be informed of allocation
Placebo
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
Province
Semnan
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, DNA damage, Apoptosis, Pre-inflammatory cytokines
ICD-10 code
ICD-10 code description

Primary outcomes

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

Description
Apoptosis
Timepoint
Before and after intervention
Method of measurement
Flow cytometry

9

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

10

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

11

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

Secondary outcomes

1

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

2

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

3

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

4

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

5

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

6

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

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
Enzymatic-colorimetric at 520 nm wavelength

10

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

11

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

12

Description
Total protein
Timepoint
Before and after intervention
Method of measurement
Biuret

13

Description
Albumin
Timepoint
Before and after intervention
Method of measurement
Bromocresol green

14

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

15

Description
Calcium
Timepoint
Before and after intervention
Method of measurement
Arsenoza

16

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

17

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

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
There will be no intervention
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
Province
Semnan
Postal code
3617753917
Phone
+98 23 3236 4499
Email
m.bagheri@shmu.ac.ir

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
Province
Semnan
Postal code
3617753917
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
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
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
Shahroud University of Medical Sciences
Full name of responsible person
Majid Bagheri Hossein Abadi
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Occupational Health
Street address
Hafte-Tir square, Shahroud University of Medical Sciences
City
Shahrood
Province
Semnan
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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Bacteriology
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
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
Consultant
Latest degree
Master
Other areas of specialty/work
Occupational Health
Street address
Shahroud University of Medical Sciences, Hafte tir Square
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3236 1718
Fax
Email
m.bagheri@shmu.ac.ir
Web page address

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Oxidative stress, DNA damage, Apoptosis, and pro-inflammatory cytokines
When the data will become available and for how long
After publishing the article
To whom data/document is available
Scientific researchers
Under which criteria data/document could be used
Without any condition
From where data/document is obtainable
Vice Chancellor for Research, Shahroud University of medical sciences
What processes are involved for a request to access data/document
By sending a request email
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