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Effect of Omega3 supplementation on Visfatin, Adiponectin, and Anthropometric indices in women with polycystic ovary syndrome

Protocol summary

Summary
Aim of this study: Effect of Omega3 supplementation on Visfatin, Adiponectin, and Anthropometric indices in women with polycystic ovary syndrome.This study is Randomized, double-blind, controlled with placebo, single-center, second phase of trial .method: The study will be conducted on 64 women with polycystic ovary syndrome (20-40y) with a BMI 25-40, refer to Reproductive Science Institute and Shahid Sadoughi hospital. The exclusion criteria is Diabetes and Hypothyroid. After checking the inclusion criteria, and filling the consent form, they will be divided in to 2groups randomly. One group will take a capsules of Omega-3 (3 g/d) and control group take placebos for 2 month. Type of the study is Randomized Double Blind Placebo-controlled Clinical Trial. criteria inclusion: females 20-40years;PCOS diagnostic according to Roterdam criteria;BMI>25; No history about intake of any drug during the last 3 months that may affect the insulin sensitivity or hormonal profile such as: oral contraceptives, glucocorticoids, ovulation induction agents, anti diabetic and anti obesity drugs, estrogenic, antiandrogenic or anti hypertensive medication. Not being in any diet in the last 3month. Do not have any addiction to tobacco and alcohol; Do not taking a Omega-3 supplement in the last 3 month; Do not be menopause; Do not use anti-coagulant medicine or anti-depression medication; Do not be diabetic and hypothyroidism. exclusion criteria:Essentially needs for intake of OCP to treatment; Do not obey the Protocols of the study and do not digest more than 20% of supplements. Blood samples (adiponectin, visfatin,LH,FSH,prolactin) and Anthropometric indices are measured before and after intervention.

General information

Acronym
PCOS، LH، FSH
IRCT registration information
IRCT registration number: IRCT2012071410281N1
Registration date: 2012-09-09, 1391/06/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-09, 1391/06/19
Registrant information
Name
Hoorieh Daneshbodi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 9836
Email address
h_daneshbodi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute for Reproductive Sciences, Research and Clinical Center for Infertility,Shahid Sadoughi University Of Medical Sciences and Health Services
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Omega3 supplementation on Visfatin, Adiponectin, and Anthropometric indices in women with polycystic ovary syndrome
Public title
Effect of Omega 3 supplementation in women with polycystic ovary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
criteria inclusion: females 20-40years; PCOS diagnostic according to Roterdam criteria; BMI>25; No history about intake of any drug during the last 3 months that may affect the insulin sensitivity or hormonal profile such as: oral contraceptives, glucocorticoids, ovulation induction agents, anti diabetic and anti obesity drugs, estrogenic, antiandrogenic or anti hypertensive medication; Not being in any diet in the last 3month; Do not have any addiction to tobacco and alcohol; Do not taking a Omega-3 supplement in the last 3 month; Do not be menopause; Do not use anti-coagulant medicine; Do not use anti-depression medication; Do not be diabetic and hypothyroidism. exclusion criteria: Essentially needs for intake of OCP to treatment; Do not will to be in the study; Do not obey the Protocols of the study and do not digest more than 20% of supplements.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid sadoughi university of medical sciences and health servicesInstitute for Reproductive Scienc
Street address
yazd-Safaeeye-Bouali avenue,infertility research center.
City
yzad
Postal code
8916877391
Approval date
2011-10-23, 1390/08/01
Ethics committee reference number
2162

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Sclerocystic ovary syndrome Stein-Leventhal syndrome

Primary outcomes

1

Description
serum visfatin-
Timepoint
before and after intervention
Method of measurement
visfatin ng/ml Elisa kit-

2

Description
serum adiponectin
Timepoint
before and after intervention
Method of measurement
adiponectin Elisa kit μg/ml-

3

Description
serum LH
Timepoint
before and after intervention
Method of measurement
LH Elisa kit U/l

4

Description
serum FSH
Timepoint
before and after intervention
Method of measurement
FSHElisa kit U/l-

5

Description
serum Prolactin
Timepoint
before and after intervention
Method of measurement
prolactin Elisa ng/mL

6

Description
body weight
Timepoint
before and after intervention
Method of measurement
leveled platform scale

7

Description
BMI-
Timepoint
before and after intervention
Method of measurement
leveled platform scale-stadiometer

8

Description
waist circumference
Timepoint
before and after intervention
Method of measurement
tape

9

Description
hip circumference
Timepoint
before and after intervention
Method of measurement
tape

Secondary outcomes

empty

Intervention groups

1

Description
intervention:capsules of fish-oil (3 g/d) for 2 month
Category
Placebo

2

Description
placebos of fish-oil (3 g/d) for 2 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Institute for Reproductive Sciences, Research and clinical Center for Infertility
Full name of responsible person
Hoorieh Daneshbodi
Street address
yazd-Safaeeye-Bouali avenue,Institute for Reproductive Sciences, Research and clinical Center for Infertility
City
yazd

2

Recruitment center
Name of recruitment center
shahid sadoughi hospital
Full name of responsible person
Hoorieh Daneshbodi
Street address
Atlasi square-shahid ghandi Boulevard-ebne sina street
City
yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Institute for Reproductive Sciences, Research and clinical Center for Infertility
Full name of responsible person
Dr Ali Mohammad Abdoli
Street address
yazd-Safaeeye-Bouali avenue-Institute for Reproductive Sciences, Research and clinical Center for Infertility
City
yazd
Grant name
151450
Grant code / Reference number
151450
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute for Reproductive Sciences, Research and clinical Center for Infertility
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
Shahid sadoughi university of medical sciences and health services
Full name of responsible person
Hoorieh Daneshbodi
Position
-Executive-Ms,c student in nutrition and health science
Other areas of specialty/work
Street address
yazd-Safaeeye-Bouali avenue,Institute for Reproductive Sciences, Research and clinical Center for Infertility
City
yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
h_daneshbodi@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid sadoughi university of medical sciences and health services-health college
Full name of responsible person
Dr Azadeh Najarzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Daneshjoo Blv-Shahid sadoughi university of medical sciences and health services-health college
City
yazd
Postal code
8916856386
Phone
+98 35 1624 0691
Fax
+98 35 1826 4931
Email
azadnajarzadeh@ssu.ac.ir
Web page address
www.ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid sadoughi university of medical sciences and health services
Full name of responsible person
Hoorieh Daneshbodi
Position
Executive-Ms,c student in nutrition and health science
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
h_daneshbodi@ssu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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