History
# Registration date Revision Id
2 2023-04-15, 1402/01/26 262355
1 2018-02-17, 1396/11/28 37422
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  • General information

    empty
    The updating process was done after publishing the paper to correct the registration information.
    empty
    پروسه بروزرسانی پس از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
    empty
    empty
  • Primary outcomes

    #1
    In serum sample will assessed by ELISA kit. μIU/ml
    ELISA kit
    انجام آزمایش بر روی سرم به روش الایزا بر حسب میکرو واحد بین المللی بر میلی لیتر
    کیت الایزا
    #2
    Free Testosterone
    SHBG
    تستوسترون آزاد
    SHBG
    In serum sample will assessed by ELISA kit. μIU/ml
    ELISA kit
    انجام آزمایش بر روی سرم به روش الایزا بر حسب میکرو واحد بین المللی بر میلی لیتر
    کیت الایزا
    #3
    DHEA Sulfate
    Serum insulin
    DHEA سولفاته
    انسولین سرم
    In serum sample will assessed by ELISA kit. μIU/ml
    Elisa kit
    انجام آزمایش بر روی سرم به روش الایزا بر حسب میکرو واحد بین المللی بر میلی لیتر
    کیت الایزا
    #4
    SHBG
    Insulin resistance
    SHBG
    مقاومت به انسولین
    In serum sample will assessed by ELISA kit. μIU/ml
    Calculated with suggested formula
    انجام آزمایش بر روی سرم به روش الایزا بر حسب میکرو واحد بین المللی بر میلی لیتر
    محاسبه شده با فرمولای پیشنهادی
    #5
    empty
    Insulin sensitivity
    empty
    حساسیت به انسولین
    empty
    At the beginning of the study and 12 weeks after intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Calculated with suggested formula
    empty
    محاسبه شده با فرمولای پیشنهادی
  • Secondary outcomes

    #1
    In serum sample will assessed by cholorimetric method. µmol/L
    In plasma sample will assessed by cholorimetric method. µmol/L
    انجام آزمایش بر روی سرم به روش رنگ سنجی بر حسب میکرو مول بر لیتر
    انجام آزمایش بر روی پلاسما به روش رنگ سنجی بر حسب میکرو مول بر لیتر
    #2
    In serum sample will assessed by cholorimetric method. µmol/L
    In plasma sample will assessed by cholorimetric method. µmol/L
    انجام آزمایش بر روی سرم به روش رنگ سنجی بر حسب میکرو مول بر لیتر
    انجام آزمایش بر روی پلاسما به روش رنگ سنجی بر حسب میکرو مول بر لیتر
    #3
    In serum sample will assessed by cholorimetric method. µmol/L
    In plasma sample will assessed by cholorimetric method. µmol/L
    انجام آزمایش بر روی سرم به روش رنگ سنجی بر حسب میکرو مول بر لیتر
    انجام آزمایش بر روی پلاسما به روش رنگ سنجی بر حسب میکرو مول بر لیتر
    #4
    empty
    High-sensitivity C-reactive protein
    empty
    پروتئین واکنشگر C با حساسیت بالا
    empty
    At the beginning of the study and 12 weeks after intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #5
    empty
    Nitric oxide
    empty
    نیتریک اکساید
    empty
    At the beginning of the study and 12 weeks after intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    In plasma sample will assessed by cholorimetric method. µmol/L
    empty
    انجام آزمایش بر روی پلاسما به روش رنگ سنجی بر حسب میکرو مول بر لیتر
    #6
    empty
    Beck score
    empty
    امتیاز بک
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #7
    empty
    GHQ score
    empty
    امتیاز سلامت عمومی
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #8
    empty
    DASS-28 score
    empty
    امتیاز DASS-28
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #9
    empty
    Modified Ferriman Gallwey
    empty
    فری من گال وی تعدیل شده
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #10
    empty
    Triglycerides
    empty
    تری گلیسرید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #11
    empty
    VLDL-cholesterol
    empty
    کلسترول VLDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #12
    empty
    Total cholesterol
    empty
    توتال کلسترول
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #13
    empty
    LDL-cholesterol
    empty
    کلسترول LDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #14
    empty
    HDL-cholesterol
    empty
    کلسترول HDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #15
    empty
    Fasting plasma glucose
    empty
    قند خون پلاسمایی ناشتا
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
  • Recruitment centers

    #1
    Name of recruitment center - English: Women's Clinic of Naghavi Hospital
    Name of recruitment center - Persian: کلینیک زنان بیمارستان نقوی
    Full name of responsible person - English: Dr. Fatemeh Forouzan Fard
    Full name of responsible person - Persian: دکتر فاطمه فروزان فرد
    Street address - English: Ayatollah Kashai Avenue, Naghavi Hospital
    Street address - Persian: خیابان آیت اله کاشانی، بیمارستان نقوی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Women's Clinic of Naghavi Hospital
    Name of recruitment center - Persian: کلینیک زنان بیمارستان نقوی
    Full name of responsible person - English: Dr. Fatemeh Forouzan Fard
    Full name of responsible person - Persian: دکتر فاطمه فروزان فرد
    Street address - English: Naghavi Hospital, Ayatollah Kashai Ave
    Street address - Persian: بیمارستان نقوی، خیابان آیت اله کاشانی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5554 0021
    Fax:
    Email: fbahmani@kaums.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی، دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Dr. Gholam Ali Hamidi
    Full name of responsible person - Persian: دکتر غلامعلی حمیدی
    Street address - English: Vice chancellor for research, Kashan University of Medical Sciences ,Ravand road
    Street address - Persian: جاده راوند، دانشگاه علوم پزشکی کاشان، معاونت پژوهشی دانشگاه
    City - English: Kashan
    City - Persian: کاشان
    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. Gholam Ali Hamidi
    Full name of responsible person - Persian: دکتر غلامعلی حمیدی
    Street address - English: Vice chancellor for research, Kashan University of Medical Sciences ,Ravand road
    Street address - Persian: معاونت پژوهشی دانشگاه، دانشگاه علوم پزشکی کاشان، جاده راوند
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5554 2999
    Fax:
    Email: hamidi_gh@kaums.ac.ir
    Web page address:

Protocol summary

Study aim
The effects of fish oil supplementation on hormonal profiles and oxidative stress parameters in patients with polycystic ovary syndrome
Design
In this research, 60 patients with polycystic ovary syndrome who are eligible will be selected. Participants are randomly divided into two groups of intervention and control by computer software. The design of the study is parallel blind randomized clinical trial.
Settings and conduct
60 patients with polycystic ovary syndrome who are eligible and are referred to women sections of Naghavii hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. The design of the study is a double blind randomized clinical tria. Blinding is carried out for patients and researchers and randomization is done by random table numbers. Patients will be assigned to receive either fish oil (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12 week intervention
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women with polycystic ovary syndrome aged 18 to 35 years, on the basis of Rotterdam criteria and without smoking abuse will be included in this study. Exclusion Criteria: Patients who do not want to cooperate؛ patients with polycystic ovary syndrome with revealed diabetes, hypo or hyperthyroidism, hyperprolactinemia are excluded from this study.
Intervention groups
Patients will be assigned to receive either fish oil (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
serum levels of total testosterone, Free testosterone, DHEA sulfate, SHBG, oxidative stress factors such as malondialdehyde (MDA), glutathione (GSH), total antioxidant capacity will be measured.

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: IRCT20150606022562N4
Registration date: 2018-02-17, 1396/11/28
Registration timing: retrospective

Last update: 2023-04-22, 1402/02/02
Update count: 1
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Fereshteh Bahmani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
fbahmani@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of fish oil supplementation on hormonal profiles and oxidative stress parameters in patients with polycystic ovary syndrome
Public title
The effect of fish oil in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-35 Polycystic ovary syndrome on the basis of Rotterdam criteria No smoking
Exclusion criteria:
Revealed diabetes Hypothyroidism or hyperthyroidism Hyperprolactinemia Cushing's syndrome and adrenal and ovarian tumors Unwillingness to continue cooperation No regular use of the prescribed supplement
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is that women with PCOS are based on two criteria: BMI (25BMI <and 25BMI≥) and age (30 and 30 ≤) in the stratification they take. The method of randomization with a simple method and the use of random numbers generated by computer software will be performed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, researchers, data collectors, evaluators and data analyzers are not aware of which group of placebo and supplemented fish oil groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan university of medical sciences and health services
Street address
Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2017-10-19, 1396/07/27
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.25

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
Total Testosterone
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
ELISA kit

2

Description
SHBG
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
ELISA kit

3

Description
Serum insulin
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Elisa kit

4

Description
Insulin resistance
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Calculated with suggested formula

5

Description
Insulin sensitivity
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Calculated with suggested formula

Secondary outcomes

1

Description
Total Gluthatione
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
In plasma sample will assessed by cholorimetric method. µmol/L

2

Description
plasma total antioxidant
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
In plasma sample will assessed by cholorimetric method. µmol/L

3

Description
Malondialdehyde (MAD)
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
In plasma sample will assessed by cholorimetric method. µmol/L

4

Description
High-sensitivity C-reactive protein
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Elisa kit

5

Description
Nitric oxide
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
In plasma sample will assessed by cholorimetric method. µmol/L

6

Description
Beck score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire

7

Description
GHQ score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire

8

Description
DASS-28 score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire

9

Description
Modified Ferriman Gallwey
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire

10

Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

11

Description
VLDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

12

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

13

Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

14

Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

15

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

Intervention groups

1

Description
Intervention: received two capsules of 1gr fish oil daily for 12 weeks
Category
Treatment - Other

2

Description
control: received two capsules of placebo daily for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Women's Clinic of Naghavi Hospital
Full name of responsible person
Dr. Fatemeh Forouzan Fard
Street address
Naghavi Hospital, Ayatollah Kashai Ave
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
fbahmani@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Vice chancellor for research, Kashan University of Medical Sciences ,Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Fereshteh Bahmani
Position
Associate Professor/ Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Biochemistry
Street address
Medical Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
Email
bahmani@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fereshteh Bahmani
Position
Associate Professor/ Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Biochemistry
Street address
Medical Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
Email
fbahmani@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fereshteh Bahmani
Position
Associate Professor/ Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Biochemistry
Street address
Medical Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
Email
fbahmani@kaums.ac.ir
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
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