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
Acronym
IRCT registration information
IRCT registration number:IRCT20150606022562N4
Registration date:2018-02-17, 1396/11/28
Registration timing:retrospective
Last update:2018-02-17, 1396/11/28
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
Postal code
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
In serum sample will assessed by ELISA kit. μIU/ml
2
Description
Free Testosterone
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
In serum sample will assessed by ELISA kit. μIU/ml
3
Description
DHEA Sulfate
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
In serum sample will assessed by ELISA kit. μIU/ml
4
Description
SHBG
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
In serum sample will assessed by ELISA kit. μIU/ml
Secondary outcomes
1
Description
Total Gluthatione
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
In serum 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 serum 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 serum sample will assessed by cholorimetric method. µmol/L
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
Ayatollah Kashai Avenue, Naghavi Hospital
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, 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
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