The Effects of Omega-3 plus Vitamin E on Metabolic Syndrome Indicators And insulin resistance in Overweight Women with polycystic ovary syndrome (pcos)
Design
Sample size was assessed by a formula suggested for randomized clinical trials 2 gruop and each group 32 participants for Randomization use of Simple randomization . A written consent form was signed by all participants following an explanation of the study and its implementation process.
Settings and conduct
The patients were recruited from women referring to Isfahan Shahid Beheshti Hospital, in the city of Isfahan in Iran.
Participants/Inclusion and exclusion criteria
diabetes, hepatitis, non-alcoholic fatty liver, kidney diseases, thyroid disorders, cardiovascular diseases and Cushing's syndrome were excluded.
oligo-ovulation or anovulation, the manifestation of hyper-androgenemia and the viewing of polycystic ovaries in ultrasound, the existence of two of which implicates the diagnosis of PCOS
Intervention groups
The participants were instructed to take two omega-3 pills (containing 180 mg eicosapentaenoic acid(EPA) and 120 mg docosahexaenoic acid( DHA)) and a pearl vitamin E (400 IU) or placebos (liquid paraffin) every day for 8 weeks
Main outcome variables
reduction in the values of TG, FBS, total Cholesterol, LDL-C, systolic blood pressure (SBP), diastolic blood pressure (DBP) and insulin serum concentration, and significantly enhances HDL-C levels
General information
Reason for update
Acronym
pcos
IRCT registration information
IRCT registration number:IRCT20200812048379N1
Registration date:2020-10-26, 1399/08/05
Registration timing:retrospective
Last update:2020-10-26, 1399/08/05
Update count:0
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
Fateme Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3788 3449
Email address
minasadeghi294@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-05-08, 1397/02/18
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-12-31, 1397/10/10
Scientific title
The Effects of Omega-3 plus Vitamin E on Metabolic Syndrome Indicators And insulin resistance in Overweight Women with Polycystic Ovary Syndrome
Public title
The Effects of Omega-3 plus Vitamin E on Metabolic Syndrome Indicators And insulin resistance in Overweight Women with Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
oligo-ovulation or anovulation
the manifestation of hyper-androgenemia or symptom of hyperandrogenism
the viewing of polycystic ovaries in ultrasound
After selecting the participants for the study, we assigned the participants to the study groups using Random Allocation software. Since we had two groups in this study, we specified the number of participants and the number of groups in the software. In addition, we will choose a simple randomization method. Entered the study was also based on software output. In this study, the physician who selected patients based on inclusion and non-inclusion criteria was not aware of the software output and only after selecting the project manager based on the patient's choice and based on the software output assigned each intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects were randomly divided in to two groups of A and B by computer and zero and one digits of Simple randomization . Researchers and subjects didn't know which groups take supplement or placebo until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Isfahan University Of Medical Sciences ;Isfahan, Iran
City
اصفهان
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2016-09-20, 1395/06/30
Ethics committee reference number
IR.MUI.REC.1395.3.407
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
FBS
Timepoint
beginning study befor of using supplement and the end of the study after completion supplement.
Method of measurement
10cc of venous blood was collected before and after the trial and after measuring with special kits.
2
Description
Triglyceride
Timepoint
beginning study befor of using supplement and the end of the study after completion supplement.
Method of measurement
10cc of venous blood was collected before and after the trial and after measuring with special kits.
3
Description
Low density lipoproteien
Timepoint
beginning study befor of using supplement and the end of the study after completion supplement.
Method of measurement
10cc of venous blood was collected before and after the trial and after measuring with special kits.
4
Description
Fasting insulin
Timepoint
beginning study befor of using supplement and the end of the study after completion supplement.
Method of measurement
10cc of venous blood was collected before and after the trial and after measuring with special kits.
5
Description
Ligh density lipoproteien
Timepoint
beginning study befor of using supplement and the end of the study after completion supplement.
Method of measurement
10cc of venous blood was collected before and after the trial and after measuring with special kits.
6
Description
Waist cicumfrance
Timepoint
beginning study befor of using supplement and the end of the study after completion supplement.
Method of measurement
was measured in standing position from the lowest rib to the extremity of the pelvic bone fracture using an anthropometric meter.
7
Description
systolic blood pressure
Timepoint
beginning study befor of using supplement and the end of the study after completion supplement.
Method of measurement
after 5 minut of rest with mercury barometer
8
Description
diastolic blood pressure
Timepoint
beginning study befor of using supplement and the end of the study after completion supplement.
Method of measurement
after 5 minut of rest with mercury barometer.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: every day 2 capsul 1000mg Omega 3 and one 400 IU vitamin E of DANA factory for 60 days.
Category
Treatment - Drugs
2
Description
Control group:every day 2 plasebo of omega 3 and one plasebo of vitamin E same of intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti Hospital
Full name of responsible person
Fateme sadeghi
Street address
Shahid Beheshti Avenue
City
اصفهان
Province
Isfehan
Postal code
8178634514
Phone
+98 31 3668 1378
Email
am.alavi@nutr.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir mansur alavi
Street address
Hezar jarib Avenue
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 1378
Email
am.alavi@nutr.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir mansur alavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib avenue
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 1378
Email
am.alavi@nutr.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir mansur alavi
Position
استاد دانشگاه
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib avenue
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 1378
Email
am.alavi@nutr.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir mansur alavi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib Avenue
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 1378
Email
am.alavi@nutr.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD