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Effect of quercetin supplementation on serum level of Asymmetric Dimethylarginine in patients in the chronic Phase of Ischemic stroke

Protocol summary

Summary
This study is a double-blind clinical trial. Seventy two patients who are in the chronic phase of ischemic stroke (6 month-2 years), 50- 75 years old, Body mass index between 25- 35 will be selected. At first the disease in patients is diagnosed by a neurologist and if there are no exclusion criteria include Body mass index more than 35, Body mass index under 25, liver disease, kidney disease, hypo or hyper thyroid, Hemorrhagic stroke, Hormone therapy (HRT), intake of warfarin, they have the permission to participate in this study. Patients will be divided randomly into two groups. Thirty six patients in the intervention group will receive 2 capsules of 500 mg quercetin twice daily for two months. Thirty six patients in the control group will receive 2 capsules placebo twice daily for two months. We need blood samples of these patients at the beginning and the end of the study for comparison and evaluation of serum levels of Asymmetric Dimethylarginine, fasting blood sugar and lipid profile. Moreover we measure weight, height and blood pressure`s patients at the beginning and the end of study.Besides we have 24 hour recall questionnaires in order to check dietary intake of macronutrients and micronutrients in the first 3 days and last 3 days of supplementation. The data will analyze in SPSS.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202269142N1
Registration date: 2012-08-04, 1391/05/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-04, 1391/05/14
Registrant information
Name
Farnaz Esmaeelzadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2620 1922
Email address
farnaz_2500@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-20, 1391/03/31
Expected recruitment end date
2012-09-19, 1391/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of quercetin supplementation on serum level of Asymmetric Dimethylarginine in patients in the chronic Phase of Ischemic stroke
Public title
Effect of quercetin in treatment of stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients in the chronic phase of ischemic stroke ( 6 month- 2 years), 50- 75 years old, Body mass index between 25- 35. Exclusion criteria: Body mass index more than 35, Body mass index under 25, liver disease, kidney disease, hypo or hyper thyroid, Hemorrhagic stroke, Hormone therapy (HRT), intake of warfarin.
Age
From 50 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 72
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
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor, Central building of Tehran University, Ghods St., Keshavarz blvd
City
Tehran
Postal code
Approval date
2012-06-05, 1391/03/16
Ethics committee reference number
91/د/130/264

Health conditions studied

1

Description of health condition studied
cerebral infarction( ischemic stroke)
ICD-10 code
I63
ICD-10 code description
Cerebral infarction

Primary outcomes

1

Description
Asymmetric Dimethylarginine
Timepoint
Start of survey and end of the second month
Method of measurement
Micromol/L with Human ADMA ELISA Kit

Secondary outcomes

1

Description
Total cholesterol
Timepoint
Start of survey and end of the second month
Method of measurement
mg/dl with kit

2

Description
Triglyceride
Timepoint
Start of survey and end of the second month
Method of measurement
mg/dl with kit

3

Description
Low density lipoprotein
Timepoint
Start of survey and end of the second month
Method of measurement
mg/dl with kit

4

Description
High density lipoprotein
Timepoint
Start of survey and end of the second month
Method of measurement
mg/dl with kit

5

Description
Fast blood glucose
Timepoint
Start of survey and end of the second month
Method of measurement
mg/dl with kit

6

Description
blood pressure
Timepoint
Start of survey and end of the second month
Method of measurement
mmgh

Intervention groups

1

Description
Quercetin, oral capsule 500 mg, twice a day in two months
Category
Treatment - Drugs

2

Description
placebo, oral capsules, twice a day in two months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Firouzgar General Hospital
Full name of responsible person
Dr. Masoud Mehrpour
Street address
Behafarin St., Hafez St., Karim khan zand St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fatouhi
Street address
Sixth floor, Central building of Tehran University, Ghods st, Keshavarz blvd
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
Farnaz Esmaeelzadeh
Position
MS student in nutrition
Other areas of specialty/work
Street address
(4th floor)department of nutrition and biochemistry, School of public health, Tehran University of Medical Sciences, Poursina St., Ghods St., Enghelab St.
City
Tehran
Postal code
Phone
+98 21 2620 1922
Fax
Email
farnaz_2500@yahoo.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
Assistant Professor
Other areas of specialty/work
Street address
School of Public health, Tehran University of Medical Sciences, Poursina St., Ghods St., Enghelab St.
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
+98 21 8895 1395
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
Farnaz Esmaeelzadeh
Position
MS student in nutrition
Other areas of specialty/work
Street address
4th floor, School of public health, Tehran University of Medical Sciences, Poursina St., Ghods St., Enghelab St.
City
Tehran
Postal code
Phone
+98 21 2620 1922
Fax
Email
farnaz_2500@yahoo.com
Web page address

Sharing plan

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