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Selenium supplementation effects on serum asymmetric dimethylarginine (ADMA) ,free androgen index (FAI) and visceral adiposity index (VAI) in women with polycystic ovary syndrome ; randomized clinical trial

Protocol summary

Summary
The study is a randomized, placebo-controlled, double blinded trial on pcos patients which is designed to examine the effects of selenium supplementaion on serum asymmetric dimethylarginine , free androgen index and visceral adiposity index in them.A total of 64 PCOs patients are selected by using Rotterdam criteria for PCOs (2003) and inclusion and exclusion criteria. Subjects are randomly divided to 2 groups. The first group receives selenium supplement; the second group receives placebo, each for 3 months. Process including: Collection of the blood samples (12 h fasting state), measurement of the serum ADMA, Apo A , APO B level before and after treatment. Measurement of lipid profile [total cholesterol, HDL-C, LDL-C and triglyceride (TG)], Hormonal parameters [ total testosterone,SHBG ], fasting plasma insulin levels, fasting plasma glucose levels and insulin resistance (according to HOMA).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014110519813N1
Registration date: 2014-12-08, 1393/09/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-08, 1393/09/17
Registrant information
Name
Fatemeh Mohammad Hosseinzade
Name of organization / entity
Tehran University Of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
fmhosseinzade@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-06-28, 1394/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Selenium supplementation effects on serum asymmetric dimethylarginine (ADMA) ,free androgen index (FAI) and visceral adiposity index (VAI) in women with polycystic ovary syndrome ; randomized clinical trial
Public title
Selenium supplementation effects on polycystic ovarian syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria are as follows: women between 18 and 45 years old; diagnosed PCOS based on the Rotterdam criteria; non smokers the exclution criteria are : having an androgen-secreting tumor, Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia, and/or virilism; impaired fasting glucose; diabetes, hypothyroidism; hyperthyroidism; liver disease; renal dysfunction; cardiovascular disease or dysfunction; pregnancy or breas feeding; taking medications known to affect metabolic parameters , such as corticosteroid drugs , ocp, selenium or multivitamin and mineral supplements -
Age
From 18 years old to 45 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
Tehran University Of Medical Sciences
Street address
Qods Ave. Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-10-21, 1393/07/29
Ethics committee reference number
1911/130/د/93

Health conditions studied

1

Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
ADMA
Timepoint
before - after 3 month treatment
Method of measurement
by elisa kit

2

Description
serum cholesterol
Timepoint
before - after 3 month treatment
Method of measurement
kit

3

Description
fasting blood sugar
Timepoint
before - after 3 month treatment
Method of measurement
torbidmetry

4

Description
serum triglyseride
Timepoint
before - after 3 month treatment
Method of measurement
kit

5

Description
HDL
Timepoint
before - after 3 month treatment
Method of measurement
kit

6

Description
LDL
Timepoint
before - after 3 month treatment
Method of measurement
friedewald equation

7

Description
APO AI
Timepoint
before - after 3 month treatment
Method of measurement
kit

8

Description
APO B100
Timepoint
before - after 3 month treatment
Method of measurement
kit

9

Description
fasting serum insulin level
Timepoint
before - after 3 month treatment
Method of measurement
kit

10

Description
testosterone
Timepoint
before - after 3 month treatment
Method of measurement
kit

11

Description
SHBG
Timepoint
before - after 3 month treatment
Method of measurement
kit

12

Description
weihgt
Timepoint
before - after 3 month treatment
Method of measurement
scale

13

Description
waist cicumfrence
Timepoint
before - after 3 month treatment
Method of measurement
Centimeter

14

Description
hip circumfernce
Timepoint
before - after 3 month treatment
Method of measurement
Centimeter

Secondary outcomes

empty

Intervention groups

1

Description
selenium, 200 microgram capsul, once a day for 3 month
Category
Treatment - Drugs

2

Description
placebo, once a day for 3 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
VALI-e-ASR Reproductive Health Research Center
Full name of responsible person
Mrs Hagholahi
Street address
Imam Khomeini Hospital Complex ,Keshavarz Blvd
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr Masoud Younesian
Street address
Sixth Floor-Central University,Qods St., Keshavarz Blvd,tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University Of Medical Sciences
Full name of responsible person
Fatemeh Mohammad Hosseinzadeh
Position
MS student of nutrition
Other areas of specialty/work
Street address
Nutrition and Diet therapy School, Naderi Ave, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
Email
fmhosseinzade@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Hosseinzadeh-Attar
Position
Assosiate professor
Other areas of specialty/work
Street address
Nutrition and Diet therapy School of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
Email
hosseinzadeh.mdphd@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Mohammad Hosseinzadeh
Position
MS student of nutrition
Other areas of specialty/work
Street address
Nutrition School of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
Email
fmhosseinzade@gmail.com
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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