Comparison of effectiveness of Omega3 supplementation on poly cystic ovary syndrome(PCOs) symptoms and metabolic syndrome according of the NIH criteria
This study aimed to determine the effectiveness of omega-3 on improving the symptoms of PCOS and the metabolic syndrome in patients with poly cystic ovarian syndrome. This study is adouble blind prospective randomized clinical trial. The study population included women with polycystic ovary syndrome will referee to two hospitals in Isfahan. Inclusion criteria: PCOS disease, according to the NIH3. Exclusion criteria: any endocrine disease.patient will take drug or placebo upon on closed pocket method. Intervention group will take omega 3 supplements with dose of 2 gr per day for six months (two capsules), but control group will receive 2 placebo capsules daily for six month. Finally, lab findings and the recovery rate of menstrual disorders and hirsutism in both groups will compare. Sample size is 44 patient in each groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604193924N3
Registration date:2017-03-10, 1395/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-10, 1395/12/20
Registrant information
Name
Behnaz Khani
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 913 314 6418
Email address
khani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of Omega3 supplementation on poly cystic ovary syndrome(PCOs) symptoms and metabolic syndrome according of the NIH criteria
Public title
Clinical trial of comparison of effectiveness of Omega-3 supplement on PCOS and metabolic syndrome with placebo
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Patients who have informed consent ; PCOS disease, according to the NIH3 ; age between 18-40 ; Exclusion criteria: smoking, use of oral pregnancy pill or alcohol or fish oil in 3 month ago or into the study ; pregnancy; have disease of kidney or liver or heart or thyroid ; diabetes ; hyperprolactinemia ; Cushing, Adrenal congenital hyperplasia, menopause ; the patient withdrew into the study ; Failure to follow the next visit
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
patient will take closed pocket and drug store dependent on number (single or pair) will give drug or placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical siences
Street address
isfahan, Hezar jerib avenue, Isfahan university of medical siences
Shahid Beheshti hospital , contra of aseman hotel, besid of Felezi bridge , Motahari avenue , Isfahan , Islamic Republic Of Iran 00989133681360 hb32us@yahoo.com
City
isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancllor for Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nemat bakhsh
Street address
Isfahan University of Medical Sciences , Isfahan , Islamic Republic Of Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancllor for Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Siencese
Full name of responsible person
Dr. Sajedhe Jafari
Position
Assistant of Gynecology
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
73461-81746
Phone
+98 913 368 1360
Fax
Email
hb32us@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Siencese
Full name of responsible person
Dr. Behnaz Khani
Position
Gynecologist and Fellowship of Infertility
Other areas of specialty/work
Street address
Department of Obstetrics , School of Medicine , Isfahan University of Medical Sciences, Isfahan , Islamic Republic Of Iran 73461-81746 00983136687898
City
Isfahan
Postal code
73461-81746
Phone
+98 31 3668 7898
Fax
Email
khani@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Sajedeh Jafari
Position
Assistant of Gynecology
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
73461-81746
Phone
Fax
Email
hb32us@yahoo.com
Web page address
http://mui.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)