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Protocol summary
This study is a double-blind clinical trial (researcher and patient) that the drug and placebo are coded by a third person who does not know about the study.Postmenopausal women referred to the menopause clinic of Imam Khomeini Hospital in Ahvaz (samples) are divided into two groups of odd and even using a table of random numbers, where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks.
This study is a double-blind clinical trial (researcher and patient) that the drug and placebo are coded by a third person who does not know about the study.Postmenopausal women referred to the menopause clinic of NajafAbad (samples) are divided into two groups of odd and even using a table of random numbers, where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks.
This study is a double-blind clinical trial (researcher and patient) that the drug and placebo are coded by a third person who does not know about the study.Postmenopausal women referred to the menopause clinic of Imam Khomeini Hospital in AhvazNajafAbad (samples) are divided into two groups of odd and even using a table of random numbers, where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks.
این مطالعه یک مطالعه کارآزمایی بالینی دو سو کور (محقق و بیمار) است که کد گذاری دارو و دارونما توسط نفر سوم که از پژوهش اطلاعی ندارد انجام می شود. زنان یائسه مراجعه کننده به درمانگاه یائسگی بیمارستان امام خمینی اهواز (نمونه ها) با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم می شوند، که گروه مداخله ویتامین e روزانه به مدت 8 هفته دریافت میکنند. گروه کنترل کپسول دارونما حاوی روغن ذرت یکبار در روز به مدت 8 هفته دریافت میکنند.
این مطالعه یک مطالعه کارآزمایی بالینی دو سو کور (محقق و بیمار) است که کد گذاری دارو و دارونما توسط نفر سوم که از پژوهش اطلاعی ندارد انجام می شود. زنان یائسه مراجعه کننده به درمانگاه یائسگی شهرستان نجف آباد (نمونه ها) با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم می شوند، که گروه مداخله ویتامین e روزانه به مدت 8 هفته دریافت میکنند. گروه کنترل کپسول دارونما حاوی روغن ذرت یکبار در روز به مدت 8 هفته دریافت میکنند.
این مطالعه یک مطالعه کارآزمایی بالینی دو سو کور (محقق و بیمار) است که کد گذاری دارو و دارونما توسط نفر سوم که از پژوهش اطلاعی ندارد انجام می شود. زنان یائسه مراجعه کننده به درمانگاه یائسگی بیمارستان امام خمینی اهوازشهرستان نجف آباد (نمونه ها) با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم می شوند، که گروه مداخله ویتامین e روزانه به مدت 8 هفته دریافت میکنند. گروه کنترل کپسول دارونما حاوی روغن ذرت یکبار در روز به مدت 8 هفته دریافت میکنند.
Intervention group: 44 Menopause women with inclusion criteria that vitamin E made by Zahravi Company of Tabriz is given 400 units daily for 8 weeks. Control group: Menopause women who have the same conditions as the intervention group, but in the control group, placebo (corn oil) made by Zahravi Company of Tabriz is used.
Intervention group: 46 Menopause women with inclusion criteria that vitamin E made by Zahravi Company of Tabriz is given 400 units daily for 8 weeks. Control group: Menopause women who have the same conditions as the intervention group, but in the control group, placebo (corn oil) made by Zahravi Company of Tabriz is used.
Intervention group: 4446 Menopause women with inclusion criteria that vitamin E made by Zahravi Company of Tabriz is given 400 units daily for 8 weeks. Control group: Menopause women who have the same conditions as the intervention group, but in the control group, placebo (corn oil) made by Zahravi Company of Tabriz is used.
گروه مداخله: 44 نفر از زنان یائسه دارای شرایط ورود به مطالعه که ویتامین e ساخت شرکت زهراوی تبریز 400واحد روزانه و به مدت 8 هفته داده می شود. گروه کنترل:زنان یائسه همان شرایط گروه مداخله را دارند ولی در گروه کنترل از دارونما (روغن ذرت) ساخت شرکت زهراوی تبریز استفاده میشود.
گروه مداخله: 46 نفر از زنان یائسه دارای شرایط ورود به مطالعه که ویتامین e ساخت شرکت زهراوی تبریز 400واحد روزانه و به مدت 8 هفته داده می شود. گروه کنترل:زنان یائسه همان شرایط گروه مداخله را دارند ولی در گروه کنترل از دارونما (روغن ذرت) ساخت شرکت زهراوی تبریز استفاده میشود.
گروه مداخله: 4446 نفر از زنان یائسه دارای شرایط ورود به مطالعه که ویتامین e ساخت شرکت زهراوی تبریز 400واحد روزانه و به مدت 8 هفته داده می شود. گروه کنترل:زنان یائسه همان شرایط گروه مداخله را دارند ولی در گروه کنترل از دارونما (روغن ذرت) ساخت شرکت زهراوی تبریز استفاده میشود.
General information
88
92
8892
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increasing the number of samples
increasing the number of samples
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افزایش تعداد نمونه ها
افزایش تعداد نمونه ها
A total of 88 Menopause women who are eligible for the study are divided into even and odd groups using a random number table. The samples are divided into two groups of odd and even using a table of random numbers. Each sample is given an envelope with the code (1 or 2) that the drug and placebo are coded by a third person who does not know about the study where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks (medicine and placebo are made by Tabriz Zahravi Pharmaceutical Company). If even numbers (0,2,4,6,8) are selected using a random number table, the envelope with code 1 is given to the samples and if odd numbers (1,3,5,7,9)are selected using a random number table, the envelope with code 2 is given to the samples.
A total of 92 Menopause women who are eligible for the study are divided into even and odd groups using a random number table. The samples are divided into two groups of odd and even using a table of random numbers. Each sample is given an envelope with the code (1 or 2) that the drug and placebo are coded by a third person who does not know about the study where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks (medicine and placebo are made by Tabriz Zahravi Pharmaceutical Company). If even numbers (0,2,4,6,8) are selected using a random number table, the envelope with code 1 is given to the samples and if odd numbers (1,3,5,7,9)are selected using a random number table, the envelope with code 2 is given to the samples.
A total of 8892 Menopause women who are eligible for the study are divided into even and odd groups using a random number table. The samples are divided into two groups of odd and even using a table of random numbers. Each sample is given an envelope with the code (1 or 2) that the drug and placebo are coded by a third person who does not know about the study where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks (medicine and placebo are made by Tabriz Zahravi Pharmaceutical Company). If even numbers (0,2,4,6,8) are selected using a random number table, the envelope with code 1 is given to the samples and if odd numbers (1,3,5,7,9)are selected using a random number table, the envelope with code 2 is given to the samples.
در مجموع 88 زن یائسه که دارای شرایط ورود به مطالعه هستند با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم میشوند.نمونه ها با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم می شوند. به هر یک از نمونه ها یک پاکت با کد (1یا2) داده میشود که کد گذاری دارو و دارونما توسط نفر سوم که از پژوهش اطلاعی ندارد انجام می شود، که گروه مداخله ویتامین e روزانه به مدت 8 هفته دریافت میکنند و گروه کنترل کپسول دارونما حاوی روغن ذرت یکبار در روز به مدت 8 هفته دریافت میکنند (دارو و دارونما توسط شرکت داروسازی زهراوی تبریز ساخته میشوند). اگر اعداد زوج (0،2،4،6،8) با استفاده از جدول اعداد تصادفی انتخاب شود، پاکت دارای کد 1 به نمونه ها داده میشود و اگر اعداد فرد (1،3،5،7،9) با استفاده از جدول اعداد تصادفی انتخاب شود، پاکت دارای کد 2 به نمونه ها داده میشود.
در مجموع 92 زن یائسه که دارای شرایط ورود به مطالعه هستند با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم میشوند.نمونه ها با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم می شوند. به هر یک از نمونه ها یک پاکت با کد (1یا2) داده میشود که کد گذاری دارو و دارونما توسط نفر سوم که از پژوهش اطلاعی ندارد انجام می شود، که گروه مداخله ویتامین e روزانه به مدت 8 هفته دریافت میکنند و گروه کنترل کپسول دارونما حاوی روغن ذرت یکبار در روز به مدت 8 هفته دریافت میکنند (دارو و دارونما توسط شرکت داروسازی زهراوی تبریز ساخته میشوند). اگر اعداد زوج (0،2،4،6،8) با استفاده از جدول اعداد تصادفی انتخاب شود، پاکت دارای کد 1 به نمونه ها داده میشود و اگر اعداد فرد (1،3،5،7،9) با استفاده از جدول اعداد تصادفی انتخاب شود، پاکت دارای کد 2 به نمونه ها داده میشود.
در مجموع 8892 زن یائسه که دارای شرایط ورود به مطالعه هستند با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم میشوند.نمونه ها با استفاده از جدول اعداد تصادفی به دو گروه زوج و فرد تقسیم می شوند. به هر یک از نمونه ها یک پاکت با کد (1یا2) داده میشود که کد گذاری دارو و دارونما توسط نفر سوم که از پژوهش اطلاعی ندارد انجام می شود، که گروه مداخله ویتامین e روزانه به مدت 8 هفته دریافت میکنند و گروه کنترل کپسول دارونما حاوی روغن ذرت یکبار در روز به مدت 8 هفته دریافت میکنند (دارو و دارونما توسط شرکت داروسازی زهراوی تبریز ساخته میشوند). اگر اعداد زوج (0،2،4،6،8) با استفاده از جدول اعداد تصادفی انتخاب شود، پاکت دارای کد 1 به نمونه ها داده میشود و اگر اعداد فرد (1،3،5،7،9) با استفاده از جدول اعداد تصادفی انتخاب شود، پاکت دارای کد 2 به نمونه ها داده میشود.
Recruitment centers
#1
Name of recruitment center - English: Menopausal clinic of Imam Khomeini
Name of recruitment center - Persian: درمانگاه یائسگی بیمارستان امام خمینی
Full name of responsible person - English: Sasan Mogahi
Full name of responsible person - Persian: ساسان موگهی
Street address - English: Azadegan Street, Imam Khomeini hospital
Street address - Persian: خیابان آزادگان، بیمارستان امام خمینی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6193673111
Phone: +98 61 3222 2114
Fax:
Email: himam@ajums.ac.ir
Web page address:
Name of recruitment center - English: Menopausal clinic of NajafAbad-Isfahan
Name of recruitment center - Persian: کلینیک یائسگی شهرستان نجف آباد-اصفهان
Full name of responsible person - English: Ali Tavakoli
Full name of responsible person - Persian: علی توکلی
Street address - English: Shahid Montazeri Hospital, Shariati Street
Street address - Persian: خیابان شریعتی، بیمارستان شهید منتظری
City - English: NajafAbad
City - Persian: نجف آباد
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 4264 1213
Fax:
Email: admin@hmn.mui.ac.ir
Web page address: https://hmn.mui.ac.ir/fa
Name of recruitment center - English: Menopausal clinic of Imam KhomeiniNajafAbad-Isfahan Name of recruitment center - Persian: درمانگاهکلینیک یائسگی بیمارستان امام خمینیشهرستان نجف آباد-اصفهان Full name of responsible person - English: Sasan MogahiAli Tavakoli Full name of responsible person - Persian: ساسان موگهیعلی توکلی Street address - English: AzadeganShahid Montazeri Hospital, Shariati Street, Imam Khomeini hospital Street address - Persian: خیابان آزادگانشریعتی، بیمارستان امام خمینیشهید منتظری City - English: AhvazNajafAbad City - Persian: اهوازنجف آباد Province: KhouzestanIsfehan Country: Iran (Islamic Republic of) Postal code: 61936731118174673461 Phone: +98 61 3222 211431 4264 1213 Fax: Email: himamadmin@ajums.ac.irhmn.mui.ac.ir Web page address: https://hmn.mui.ac.ir/fa
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Badvi
Full name of responsible person - Persian: محمد بدوی
Street address - English: Golestan Blv, Esfand Ave., Ahvaz Jundishapur University of medical Science, Ahvaz
Street address - Persian: بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6157941357
Phone: +98 61 3373 8383
Fax:
Email: info@ajums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Badvi
Full name of responsible person - Persian: محمد بدوی
Street address - English: Ahvaz Jondishapur University of Medical Sciences,Golestan Blv
Street address - Persian: دانشگاه علوم پزشکی جندی شاپور، بلوار گلستان
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6157941357
Phone: +98 61 3373 8383
Fax:
Email: info@ajums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohammad Badvi Full name of responsible person - Persian: محمد بدوی Street address - English: Golestan Blv, Esfand Ave., Ahvaz JundishapurJondishapur University of medical Science, AhvazMedical Sciences,Golestan Blv Street address - Persian: بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز، بلوار گلستان City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6157941357 Phone: +98 61 3373 8383 Fax: Email: info@ajums.ac.ir Web page address:
Protocol summary
Study aim
Investigating the effect of vitamin e on depression and anxiety in postmenopausal women
Design
Clinical trial with control group, double-blind, randomized
Settings and conduct
This study is a double-blind clinical trial (researcher and patient) that the drug and placebo are coded by a third person who does not know about the study.Postmenopausal women referred to the menopause clinic of NajafAbad (samples) are divided into two groups of odd and even using a table of random numbers, where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
At least one year passed since the last menstruation.
Menopausal Married women.
Educated.
Age between 45-65 years.
Earn a score 10-29 from Beck Depression Questionnaire for both groups.
Earn a score 8-25 from Beck Anxiety Questionnaire for both groups.
Exclusion criteria:
Consumption of vitamins and minerals, antidepressants and diuretics in the last 3 months.
Smoking history, using drugs and alcohol during the last 3 months.
History of mental or physical illness.
Occurrence of an unfortunate event during the last 6 months.
Intervention groups
Intervention group: 46 Menopause women with inclusion criteria that vitamin E made by Zahravi Company of Tabriz is given 400 units daily for 8 weeks. Control group: Menopause women who have the same conditions as the intervention group, but in the control group, placebo (corn oil) made by Zahravi Company of Tabriz is used.
Main outcome variables
Depression and anxiety of postmenopausal women
General information
Reason for update
increasing the number of samples
Acronym
IRCT registration information
IRCT registration number:IRCT20200307046719N1
Registration date:2020-12-04, 1399/09/14
Registration timing:prospective
Last update:2024-01-03, 1402/10/13
Update count:1
Registration date
2020-12-04, 1399/09/14
Registrant information
Name
Sara Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8331
Email address
soltani.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Vitamin e on Depression and Anxiety in Postmenopausal Women
Public title
The Effect of Vitamin e on Depression and Anxiety in Postmenopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year passed since the last menstruation.
Menopausal Married women.
Educated.
Ages between 45-65 years.
Earn a score 10-29 from Beck Depression Questionnaire for both groups.
Earn a score 8-25 from Beck Anxiety Questionnaire for both groups.
Exclusion criteria:
Consumption of vitamins and minerals, antidepressants and diuretics in the last 3 months.
Smoking history, using drugs and alcohol during the last 3 months.
History of mental or physical illness.
Occurrence of an unfortunate event during the last 6 months
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 92 Menopause women who are eligible for the study are divided into even and odd groups using a random number table. The samples are divided into two groups of odd and even using a table of random numbers. Each sample is given an envelope with the code (1 or 2) that the drug and placebo are coded by a third person who does not know about the study where the intervention group receives vitamin e daily for 8 weeks and the control group receives the placebo capsule containing corn oil once a day for 8 weeks (medicine and placebo are made by Tabriz Zahravi Pharmaceutical Company). If even numbers (0,2,4,6,8) are selected using a random number table, the envelope with code 1 is given to the samples and if odd numbers (1,3,5,7,9)are selected using a random number table, the envelope with code 2 is given to the samples.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding and coding of drugs and placebos (vitamin e and corn oil) is done by a third person who does not know about the research. And the required number of each drug and placebo is poured separately in packages of same shape and code 1 or 2 is given. The samples and the researcher do not know the nature of the packages until the end of the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
No. 234, Research and Development Department, Ahvaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.AJUMS.REC.1398.929
Health conditions studied
1
Description of health condition studied
Depressive and Anxiety Disorder
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Beck Anxiety Inventory
2
Description
Depression
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The vitamin e made by Zahravi Company of Tabriz 400 unit once daily for eight weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule containing corn oil made by Zahravi Company of Tabriz once daily for eight weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Menopausal clinic of NajafAbad-Isfahan
Full name of responsible person
Ali Tavakoli
Street address
Shahid Montazeri Hospital, Shariati Street
City
NajafAbad
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4264 1213
Email
admin@hmn.mui.ac.ir
Web page address
https://hmn.mui.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi
Street address
Ahvaz Jondishapur University of Medical Sciences,Golestan Blv
City
Ahvaz
Province
Khouzestan
Postal code
6157941357
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Soltani
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing And Midwifery Department,Ahvaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
8513736871
Phone
+98 61 3373 8331
Email
soltani.s@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing And Midwifery Department,Ahvaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155686453
Phone
+98 61 3373 8331
Email
Abbaspoor_z762@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Soltani
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing And Midwifery Department,Ahvaz Jondishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
8513736871
Phone
+98 61 3373 8331
Email
soltani.s@ajums.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
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
Demographic information of individuals and data before and after the intervention is reported without mentioning the name
When the data will become available and for how long
Access started in 2021
To whom data/document is available
Only researchers in the field of medical universities
Under which criteria data/document could be used
It can only be used in similar research
From where data/document is obtainable
Researcher's personal email
What processes are involved for a request to access data/document
This is done by sending an email to the researcher.