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The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes: A parallel randomized controlled clinical trial

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History
# Registration date Revision Id
2 2025-03-06, 1403/12/16 332828
1 2020-08-03, 1399/05/13 145753
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  • Protocol summary

    ٍEvaluating the effect of supplementation with organic selenium, vitamin E, and combination of organic selenium-vitamin E on peripheral neuropathy and biochemical markers in people with diabetes
    ٍEvaluating the effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with diabetes
    تعیین تاثیر مکمل یاری با سلنیوم آلی، ویتامین E ، و ترکیب سلنیوم آلی- ویتامین E بر نوروپاتی محیطی و مارکرهای بیوشیمیایی در افراد مبتلا به دیابت
    تعیین تاثیر مکمل یاری با سلنیوم آلی بر نوروپاتی محیطی و مارکرهای بیوشیمیایی در افراد مبتلا به دیابت
    This is a phase 3, triple blind randomized controlled clinical trial with a factorial design in which the target population is 100 eligible patients with peripheral diabetic neuropathy. Computer software (RAS: Random Allocation Software) will be used to randomize.
    This is a phase 3, triple blind randomized controlled clinical trial with a parallel design in which the target population is 50 eligible patients with peripheral diabetic neuropathy. Computer software (RAS: Random Allocation Software) will be used to randomize.
    این مطالعه یک کارآزمایی بالینی تصادفی کنترل شده سه سو کور فاز 3 با طرح فاکتوریل است که جمعیت هدف آن 100 نفر از بیماران مبتلا به نوروپاتی محیطی دیابتی واجد شرایط مطالعه هستند. برای تصادفی سازی از نرم افزار کامپیوتری (RAS (Random Allocation Software استفاده خواهد شد.
    این مطالعه یک کارآزمایی بالینی تصادفی کنترل شده سه سو کور فاز 3 با طرح موازی است که جمعیت هدف آن 50 نفر از بیماران مبتلا به نوروپاتی محیطی دیابتی واجد شرایط مطالعه هستند. برای تصادفی سازی از نرم افزار کامپیوتری (RAS (Random Allocation Software استفاده خواهد شد.
    Participants will be allocated into one of four groups of organic selenium, vitamin E, combination of organic selenium and vitamin E, or placebo by an allocation ratio of 1: 1: 1: 1. They will take a daily 500 mg capsule containing 400 IU of vitamin E, or 200 micrograms of selenium, or 400 IU of vitamin E-200 micrograms of selenium, or placebo.
    Participants will be allocated into one of two groups of organic selenium or placebo by an allocation ratio of 1: 1. They will take a daily 500 mg capsule containing 200 micrograms of selenium or placebo.
    افراد با نسبت تخصیص 1:1:1: 1 در یکی از چهار گروه سلنیوم آلی، ویتامین E ، ترکیب سلنیوم آلی- ویتامین E و یا گروه دارونما قرار میگیرند. افراد روزانه یکعدد کپسول500 میلی¬گرمی حاوی 400 واحد ویتامین E ، یا 200 میکروگرم سلنیوم، یا 400 واحد ویتامین E -200 میکروگرم سلنیوم، و یا دارونما کاملا مشابه مصرف خواهند کرد.
    افراد با نسبت تخصیص 1: 1 در یکی از دو گروه سلنیوم آلی و یا گروه دارونما قرار میگیرند. افراد روزانه یکعدد کپسول500 میلی گرمی حاوی 200 میکروگرم سلنیوم و یا دارونما کاملا مشابه مصرف خواهند کرد.

  • General information

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    2021-04-21, 1400/02/01
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    2024-10-22, 1403/08/01
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    2024-10-22, 1403/08/01
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    Under the above request and approval by the Center Council and Ethics Committee, the 4 study groups should be reduced to two groups: organic selenium and placebo, and the sample size should be reduced from 100 people in 4 groups to 50 people in 2 groups. Please agree.
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    با توجه به درخواست فوق و تایید شورای مرکز و کمیته اخلاق، 4 گروه مطالعه باید به دو گروه سلنیوم آلی و پلاسبو و حجم نمونه از 100نفر در 4 گروه به 50 نفر در 2 گروه کاهش یابد. لطفا موافقت فرمایید.
    The effect of supplementation with organic selenium, vitamin E, and organic selenium-vitamin E on peripheral neuropathy and biochemichal markers in people with melitus diabetes.
    The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes.
    تاثیر مکمل یاری با سلنیوم آلی، ویتامین E ، و سلنیوم آلی- ویتامین E بر نوروپاتی محیطی و مارکرهای بیوشیمیایی در افراد مبتلا به دیابت.
    تاثیر مکمل یاری با سلنیوم آلی بر نوروپاتی محیطی و مارکرهای بیوشیمیایی در افراد مبتلا به دیابت.
    The effect of supplementation with organic selenium, vitamin E, and organic selenium-vitamin E on peripheral neuropathy and biochemichal markers in people with melitus diabetes: factorial randomized controlled clinical trial.
    The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes: A parallel randomized controlled clinical trial
    تاثیر مکمل یاری با سلنیوم آلی، ویتامین E ، و سلنیوم آلی- ویتامین E بر نوروپاتی محیطی و مارکرهای بیوشیمیایی در افراد مبتلا به دیابت: کارآزمایی بالینی تصادفی کنترل شده با طرح فاکتوریل.
    تاثیر مکمل یاری با سلنیوم آلی بر نوروپاتی محیطی و مارکرهای بیوشیمیایی در افراد مبتلا به دیابت: کارآزمایی بالینی تصادفی کنترل شده با طرح موازی
    Participants will be allocated into one of the four groups of organic selenium, vitamin E, combination of organic selenium-vitamin E, or Placebo using computer software (RAS: Random Allocation Software) by four and 8 blocks with a 1: 1: 1: 1 allocation ratio . . Random allocation sequences will be generated by the non-involved person in the research. The flacons will be numbered from 1 to 100 based on the sequence produced.
    Participants will be allocated into one of the two groups of organic selenium or placebo using computer software (RAS: Random Allocation Software) by four and 8 blocks with a 1:1 allocation ratio. Random allocation sequences will be generated by the non-involved person in the research. The flacons will be numbered from 1 to 50 based on the sequence produced.
    افراد با استفاده از نرم افزار کامپیوتری (RAS: Random Allocation Software) از طریق بلوک بندی چهار و 8تایی با نسبت تخصیص 1:1:1: 1 در یکی از چهار گروه سلنیوم آلی، ویتامین E ، ترکیب سلنیوم آلی- ویتامین E و یا گروه دارونما قرار میگیرند. توالی تصادفی تخصیص توسط فرد غیردرگیر در پژوهش تولید خواهد شد. فلاکنها بر اساس توالی تولید شده از 1 تا 100 شماره گذاری خواهد شد.
    افراد با استفاده از نرم افزار کامپیوتری (RAS: Random Allocation Software) از طریق بلوک بندی چهار و 8تایی با نسبت تخصیص 1: 1 در یکی از دو گروه سلنیوم آلی و یا گروه دارونما قرار میگیرند. توالی تصادفی تخصیص توسط فرد غیردرگیر در پژوهش تولید خواهد شد. فلاکنها بر اساس توالی تولید شده از 1 تا 50 شماره گذاری خواهد شد.
    Each person will be given a 60-capsule, mattee, and enclosed flacons consisted of identical main medications or placebos for bi-monthly use that will be provided at the Nutrition Research Center. They will receive 500 mg capsule once a day containing 400 IU vitamin E , or 200 micrograms selenium, or 400 IU vitamin E along with 200 micrograms selenium, or placebo. All capsules will be identical, and all participants, researchers (who will also be evaluators of the outcomes), health care providers, and the Data Safety and Monitoring Committee will be blind.
    Each person will be given a 60-capsule mattee and enclosed flacons consisting of identical main medications or placebos for bi-monthly use that will be provided at the Nutrition Research Center. They will receive 500 mg capsules once a day containing 200 micrograms of selenium or placebo. All capsules will be identical, and all participants, researchers (who will also be evaluators of the outcomes), health care providers, and the Data Safety and Monitoring Committee will be blind.
    به هر فرد فلاکن مات سریسته دارویی حاوی 60 عدد کپسول برای مصرف دو ماهانه یا دارونمای کاملا مشابه آن که در مرکز نحقیقات تغذیه تهیه خواهد شد داده میشود تا روزانه یکعدد کپسول500 میلیگرمی حاوی 400 واحد ویتامین E ، یا 200 میکروگرم سلنیوم، یا 400 واحد ویتامین ای -200 میکروگرم سلنیوم، و یا دارونما مصرف نمایند. همه کپسول ها ظاهر کاملا یکسانی خواهند داشت و همه شرکت کنندگان، محققین (که ارزیابی کنندگان پیامدها نیز خواهند بود)، مراقبین سلامت، و کمیته ایمنی و نظارت بر داده ها کور خواهند بود.
    به هر فرد یک ظرف سر بسته دارویی حاوی 60 عدد کپسول برای مصرف دو ماهانه یا دارونمای کاملا مشابه آن که در مرکز تحقیقات تغذیه تهیه خواهد شد داده میشود تا روزانه یکعدد کپسول 500 میلیگرمی حاوی 200 میکروگرم سلنیوم و یا دارونما مصرف نمایند. همه کپسول ها ظاهر کاملا یکسانی خواهند داشت و همه شرکت کنندگان، محققین (که ارزیابی کنندگان پیامدها نیز خواهند بود)، مراقبین سلامت، و کمیته ایمنی و نظارت بر داده ها کور خواهند بود.

  • Secondary outcomes

    #1
    DHEA serum levels
    Quality of life score
    سطح سرمی DHEA
    نمره کیفیت زندگی
    Using Elisa method
    World Health Organization quality of life assessment instrument (WHOQOL -BREF)
    به روش الایزا
    پرسشنامه کیفیت زندگی سازمان جهانی بهداشت (WHOQOL -BREF)
    #2
    Quality of life score
    Depression score
    نمره کیفیت زندگی
    نمره افسردگی
    World Health Organization quality of life assessment instrument (WHOQOL -BREF)
    Beck Depression Inventory-2
    پرسشنامه کیفیت زندگی سازمان جهانی بهداشت (WHOQOL -BREF)
    پرسشنامه افسردگی بک دو
    #3
    Depression score
    Sleep quality score
    نمره افسردگی
    نمره کیفیت خواب
    Beck Depression Inventory-2
    Pittsburgh Sleep Quality Questionnaire
    پرسشنامه افسردگی بک دو
    پرسشنامه کیفیت خواب پیتزبرگ
    #4
    Sleep quality score
    Sexual satisfaction score
    نمره کیفیت خواب
    نمره رضایت جنسی
    Pittsburgh Sleep Quality Questionnaire
    Larson's sexual satisfaction questionnaire (LSSQ)
    پرسشنامه کیفیت خواب پیتزبرگ
    پرسشنامه رضایت جنسی لارسون (LSSQ)
    #5
    Sexual satisfaction score
    Side effects
    نمره رضایت جنسی
    عوارض جانبی
    Larson's sexual satisfaction questionnaire (LSSQ)
    Questionnaire
    پرسشنامه رضایت جنسی لارسون (LSSQ)
    پرسشنامه
    #6
    Side effects
    Satisfaction with medication
    عوارض جانبی
    میزان رضایت از مصرف داروها
    Questionnaire
    Satisfaction rate questionnaire
    پرسشنامه
    پرسشنامه میزان رضایت
    #7
    Satisfaction with medication
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    میزان رضایت از مصرف داروها
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    Baseline and 8 weeks after intervention
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    قبل و 8 هفته بعد از مداخله
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    Satisfaction rate questionnaire
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    پرسشنامه میزان رضایت
    empty

  • Intervention groups

    #1
    Intervention group 1: Organic selenium group. They will take one 500 mg oral capsule containing 200 micrograms of selenium daily for 8 weeks. Organic selenium will be produced at the Nutrition Research Center.
    Intervention group 1: Organic selenium group. They will take one 500 mg oral capsule containing 200 micrograms of selenium daily for 8 weeks. Organic selenium will be produced by the yeast Saccharomyces cerevisiae from sodium selenite. The rest of the capsule space will be filled with yeast powder. Organic selenium will be produced at the Nutrition Research Center.
    گروه مداخله 1: گروه سلنیوم آلی. روزانه یکعدد کپسول500 میلی گرمی خوراکی حاوی 200 میکروگرم سلنیوم به مدت 8 هفته مصرف خواهند نمود. سلنیوم آلی در مرکز نحقیقات تغذیه تهیه خواهد شد.
    گروه مداخله 1: گروه سلنیوم آلی. روزانه یکعدد کپسول500 میلی گرمی خوراکی حاوی 200 میکروگرم سلنیوم به مدت 8 هفته مصرف خواهند نمود. سلنیوم آلی توسط مخمر ساکارومایسس سروزیه از سلنیت سدیم تولید خواهد شد. بقیه فضای کپسول هم با پودر مخمر پر خواهد شد. سلنیوم آلی در مرکز تحقیقات تغذیه تهیه خواهد شد.
    #2
    Treatment - Drugs
    Placebo
    Intervention group 2: Vitamin E group. They will take one 500 mg capsule daily containing 400 IU of vitamin E (alpha-tocopherol) for 8 weeks. Vitamin E capsules will be provided at the Nutrition Research Center.
    Control group: Placebo group. They will take one 500 mg capsule containing starch daily for 8 weeks. The placebo capsules will be provided at the Nutrition Research Center.
    گروه مداخله 2: گروه ویتامین E. روزانه یکعدد کپسول500 میلی گرمی حاوی 400 واحد ویتامین E (آلفا توکوفرول) به مدت 8 هفته مصرف خواهند نمود. کپسول ویتامین E در مرکز نحقیقات تغذیه تهیه خواهد شد.
    گروه کنترل: گروه دارونما. روزانه یکعدد کپسول 500 میلی گرمی حاوی نشاسته به مدت 8 هفته مصرف خواهند نمود. کپسولهای دارونما در مرکز تحقیقات تغذیه تهیه خواهد شد.
    #3
    Treatment - Drugs
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    Intervention group 3: Organic selenium and Vitamin E combined group (Interaction group) .They will take one 500 mg capsule containing 400 IU of vitamin E (alpha-tocopherol) - 200 micrograms of selenium will be consumed for 8 weeks. Vitamin E- Organic Selenium capsules will be provided at the Nutrition Research Center. In this group, concurrent and interaction effects of two independent variables will be evaluated on dependent variables. .
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    گروه مداخله 3: گروه ترکیب سلنیوم آلی- ویتامین E :. روزانه یکعدد کپسول500 میلی گرمی حاوی 400 واحد ویتامین ای- 200 میکروگرم سلنیوم به مدت 8 هفته مصرف خواهند نمود. کپسول ویتامین ای- سلنیوم آلی در مرکز نحقیقات تغذیه تهیه خواهد شد. در این گروه اثرات همزمان و متقابل دو متغیر مستقل بر روی متغیرهای وابسته ارزیابی خواهد شد.
    empty
    #4
    Placebo
    empty
    Control group: Placebo group. They will take one 500 mg capsule containing starch daily for 8 weeks. The placebo capsules will be provided at the Nutrition Research Center.
    empty
    گروه کنترل: گروه دارونما. روزانه یکعدد کپسول500 میلی گرمی حاوی نشاسته به مدت 8 هفته مصرف خواهند نمود. کپسولهای دارونما در مرکز نحقیقات تغذیه تهیه خواهد شد.
    empty

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Azizeh Farshbaf-khalili
    Full name of responsible person - Persian: عزیزه فرشباف خلیلی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
    Street address - Persian: گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، مرکز تحقیقات علوم تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 2295
    Mobile: +98 914 402 3216
    Fax:
    Email: farshbafa@tbzmed.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Azizeh Farshbaf-khalili
    Full name of responsible person - Persian: عزیزه فرشباف خلیلی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
    Street address - Persian: گلگشت، خیابان عطار نیشابوری، دانشگاه علوم پزشکی تبریز، مرکز تحقیقات علوم تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 2295
    Mobile: +98 914 402 3216
    Fax:
    Email: farshbafa@tbzmed.ac.ir
    Web page address:

Protocol summary

Study aim
ٍEvaluating the effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with diabetes
Design
This is a phase 3, triple blind randomized controlled clinical trial with a parallel design in which the target population is 50 eligible patients with peripheral diabetic neuropathy. Computer software (RAS: Random Allocation Software) will be used to randomize.
Settings and conduct
Sampling will be done in Nutrition Research Center. After the approval of the Ethics Committee and the registration of the trial in IRCT, the researcher will express the objectives of the study to the participants and obtain a form of informed consent. After completing the questionnaires, each person will be given 60 number of 500 mg identical capsules for bio-monthly use. monitoring will be blunt.Participants, researchers, analyst, and the safety and data monitoring committee will be blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women or men aged 40-70 years, type 2 diabetes based on the diagnosis of endocrinologist, peripheral diabetic neuropathy based on Michigan neuropathy screening tool. Exclusion criteria: Peripheral neuropathy due to other diseases, other chronic diseases, pregnancy, breastfeeding.
Intervention groups
Participants will be allocated into one of two groups of organic selenium or placebo by an allocation ratio of 1: 1. They will take a daily 500 mg capsule containing 200 micrograms of selenium or placebo.
Main outcome variables
Symptoms of neuropathy; Severity of neuropathy; Serum levels of glycemic markers; Serum indicator of Pro-oxidant Antioxidant Balance (PAB)

General information

Reason for update
Under the above request and approval by the Center Council and Ethics Committee, the 4 study groups should be reduced to two groups: organic selenium and placebo, and the sample size should be reduced from 100 people in 4 groups to 50 people in 2 groups. Please agree.
Acronym
IRCT registration information
IRCT registration number: IRCT20131009014957N10
Registration date: 2020-08-03, 1399/05/13
Registration timing: prospective

Last update: 2025-03-08, 1403/12/18
Update count: 1
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Azizeh Farshbaf-khalili
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 9151
Email address
farshbafa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
2021-04-21, 1400/02/01
Actual recruitment end date
2024-10-22, 1403/08/01
Trial completion date
2024-10-22, 1403/08/01
Scientific title
The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes: A parallel randomized controlled clinical trial
Public title
The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women or men aged 40-70 years Type 2 Diabetes based on the diagnosis of endocrinologist Diabetic peripheral neuropathy based on Michigan neuropathy screening tool
Exclusion criteria:
Peripheral neuropathy due to other diseases (including alcohol consumption, chemotherapy, congenital disease, chronic inflammation, thyroid disorders, vitamin B12 deficiency, HIV, and idiopathic peripheral neuropathy) Other chronic diseases such as cancer, chronic renal failure, CVA, Parkinson, Alzheimer Increased risk of bleeding due to coagulation disorders Selenium or vitamin E supplementation during last 3 months Pregnancy Breastfeeding
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated into one of the two groups of organic selenium or placebo using computer software (RAS: Random Allocation Software) by four and 8 blocks with a 1:1 allocation ratio. Random allocation sequences will be generated by the non-involved person in the research. The flacons will be numbered from 1 to 50 based on the sequence produced.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Each person will be given a 60-capsule mattee and enclosed flacons consisting of identical main medications or placebos for bi-monthly use that will be provided at the Nutrition Research Center. They will receive 500 mg capsules once a day containing 200 micrograms of selenium or placebo. All capsules will be identical, and all participants, researchers (who will also be evaluators of the outcomes), health care providers, and the Data Safety and Monitoring Committee will be blind.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Nutrition Research Center, Tabriz University of Medical Sciences; Attar Neishabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.TBZMED.REC.1399.322

Health conditions studied

1

Description of health condition studied
ِDiabetic peripheral neuropathy
ICD-10 code
G63*
ICD-10 code description
Polyneuropathy in diseases classified elsewhere

Primary outcomes

1

Description
Neuropathy symptoms
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
Michigan neuropathy screening tool

2

Description
Neuropathy severity
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
Toronto Clinical Scoring System

3

Description
Serum levels of glycemic markers (fasting blood sugar, insulin resistance, blood sugar monitored by the individual)
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
Biochemical methods and glucometer

4

Description
Pro-oxidant antioxidant balance
Timepoint
Pro-oxidant antioxidant balance
Method of measurement
Biochemical method

Secondary outcomes

1

Description
Quality of life score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
World Health Organization quality of life assessment instrument (WHOQOL -BREF)

2

Description
Depression score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Beck Depression Inventory-2

3

Description
Sleep quality score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

4

Description
Sexual satisfaction score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Larson's sexual satisfaction questionnaire (LSSQ)

5

Description
Side effects
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Questionnaire

6

Description
Satisfaction with medication
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Satisfaction rate questionnaire

Intervention groups

1

Description
Intervention group 1: Organic selenium group. They will take one 500 mg oral capsule containing 200 micrograms of selenium daily for 8 weeks. Organic selenium will be produced by the yeast Saccharomyces cerevisiae from sodium selenite. The rest of the capsule space will be filled with yeast powder. Organic selenium will be produced at the Nutrition Research Center.
Category
Treatment - Drugs

2

Description
Control group: Placebo group. They will take one 500 mg capsule containing starch daily for 8 weeks. The placebo capsules will be provided at the Nutrition Research Center.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition Research Center
Full name of responsible person
Azizeh Farshbaf-Khalili
Street address
Nutrition Research Center, Tabriz University of Medical Sciences; Attar Neishabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Fax
+98 41 3335 2295
Email
farshbafa@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Central building of Tabriz University of Medical Sciences., Azadi St., Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
Samiei.moh@gmail.com
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-khalili
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
farshbafa@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Mobasseri
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
mobasserim@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-khalili
Position
Assistant Profeassor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
farshbafa@tbzmed.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the outcome data will be published
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers at institutions have access to data
Under which criteria data/document could be used
In order to help scientific progress in the field of research
From where data/document is obtainable
farshbafa@tbzmed.ac.ir
What processes are involved for a request to access data/document
Scientific approval of applicant by Tabriz University of Medical Sciences
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