Clinical trial of the effect of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome
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Protocol summary
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil, daily, for 12 weeks orally.
Control group: Placebo pearl, daily, for 12 weeks orally.
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
Control group: Placebo pearl (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil (Barij Essence, Kashan, Iran), daily, for 12 weeks orally. Control group: Placebo pearl (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
گروه مداخله: پرل ترکیب ویتامین D و روغن گل مغربی، 1000 واحد ویتامین D بعلاوه 1000 میلی گرم روغن گل مغربی، روزانه، به صورت خوراکی برای 12 هفته.
گروه کنترل: پرل پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
گروه مداخله: پرل ترکیب ویتامین D و روغن گل مغربی، 1000 واحد ویتامین D بعلاوه 1000 میلی گرم روغن گل مغربی (باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 12 هفته.
گروه کنترل: پرل پلاسبو (باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 12 هفته.
گروه مداخله: پرل ترکیب ویتامین D و روغن گل مغربی، 1000 واحد ویتامین D بعلاوه 1000 میلی گرم روغن گل مغربی (باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 12 هفته. گروه کنترل: پرل پلاسبو (باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 12 هفته.
General information
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
The updating process was done after publishing the paper to correct the registration information.
DueThe updating process was done after publishing the paper to an error,correct the request for an update in our website was conducted after paper publishedregistration information. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
پروسه بروزرسانی پس از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
بخاطر یک اشتباه، درخواست برایپروسه بروزرسانی در وب سایت ما بعدپس از چاپانتشار مقاله به منظور تصحیح اطلاعات ثبت انجام شدگرفت. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
Secondary outcomes
#1
Hirsutism
Alopecia
HirsutismAlopecia
هیرسوتیسم
ریزش مو
هیرسوتیسمریزش مو
#2
empty
Modified Ferriman-Gallwey score
Modified Ferriman-Gallwey score
empty
امتیاز فری من-گال وی تعدیل شده
امتیاز فری من-گال وی تعدیل شده
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
#3
empty
Acne
Acne
empty
آکنه
آکنه
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Clinical observation
Clinical observation
empty
مشاهده بالینی
مشاهده بالینی
Protocol summary
Study aim
Objective: The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome (PCOS).
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: 60 patients of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 18-40 years diagnosed with PCOS.Exclusion criteria: Elevated levels of prolactin, thyroid disorder, endocrine diseases including individuals with diabetes, impaired glucose tolerance, gastrointestinal diseases.
Intervention groups
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
Control group: Placebo pearl (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
Main outcome variables
Outcomes: Lipid profiles (primary outcomes) and biomarkers of oxidative stress (secondary outcomes) will be measured at study baseline and after 12 weeks of intervention.
General information
Reason for update
The updating process was done after publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT201508025623N48
Registration date:2015-08-06, 1394/05/15
Registration timing:retrospective
Last update:2023-04-10, 1402/01/21
Update count:2
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-08-03, 1394/05/12
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-40 years diagnosed with PCOS
Exclusion criteria:
Elevated levels of prolactin
Thyroid disorder
Endocrine diseases including individuals with diabetes, impaired glucose tolerance
Gastrointestinal diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take supplements (n=30) or the standard diet (n=30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.ARAKMU.REC.1394.92
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
LDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
VLDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Secondary outcomes
1
Description
Serum vitamin D
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Alopecia
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Clinical observation
3
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Modified Ferriman-Gallwey score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
7
Description
Acne
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Clinical observation
Intervention groups
1
Description
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil, daily, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo pearl, daily, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar outpatient Clinic
Full name of responsible person
Khadijeh Nasri
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 84 3223 3823
Email
nasri-k@aums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 84 3223 3823
Email
research@aums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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