This study is designed to determine the effect of Fish Oil (FO) supplements on High density lipoprotein cholesterol (HDL-C), Apolipoprotein-AI (Apo-AI), Malondialdehyde (MDA), Arylesterase (Aryl) and Paraoxonase (PON1) activity in female rheumatoid arthritis patients (RA).
80 RA patients will be divided randomly to 40 plasebo and 40 FO groups. FO group will treat with one pearl Fish Oil and placebo group with palsebo daily for 3 months accompany with conventional drug, respectively. Apo-AI, PON1, HDL, , MDA, and and Arylesterase will be measure in blood samples before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902073812N1
Registration date:2010-06-07, 1389/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-07, 1389/03/17
Registrant information
Name
Amir Ghorbanihaghjo
Name of organization / entity
Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz 51664, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3234
Email address
ghorbani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-Chancellor, Tabriz University of Medical Sciences
Expected recruitment start date
2009-08-22, 1388/05/31
Expected recruitment end date
2010-06-11, 1389/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Fish Oil supplements on Serum paraoxonase activity in female patients with rheumatoid arthritis
Public title
Effect of Fish Oil supplements on Serum paraoxonase activity in female patients with rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Female - patients with rheumatoid arthritis - fixed and regular therapeutic schedule
Age
From 10 years old to 80 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethic committee of tabriz university of medical sciences
Street address
Ethic committee of tabriz university of medical sciences
City
Tabriz
Postal code
51664
Approval date
2009-06-08, 1388/03/18
Ethics committee reference number
2423/4/5
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05.3
ICD-10 code description
rheumatoid arthritis
Primary outcomes
1
Description
Paraoxonase Enzyme
Timepoint
3 months
Method of measurement
spectrophotometric method
Secondary outcomes
1
Description
Study of lipid profile
Timepoint
3 months
Method of measurement
Biochemical methods
2
Description
Improve Apo a1 levels
Timepoint
3 months
Method of measurement
Turbidimetry
Intervention groups
1
Description
Omega3
Category
Prevention
2
Description
placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amam Reza Hospital - Tabriz University of Medical sciences
Full name of responsible person
Dr Kolahi
Street address
Amam Reza Hospital- - Tabriz University of Medical sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences -Research Vice-Chancellor
Full name of responsible person
Dr Rashidi Head of Research Vice-Chancellor
Street address
Tabriz University of Medical sciences . Research Vice-Chancellor
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences -Research Vice-Chancellor
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
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Amir Ghorbanihaghjo
Position
University teacher
Other areas of specialty/work
Street address
Biochemistry Department - Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1336 3234
Fax
Email
ghorbaniamir@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Tabriz, Iran.
Full name of responsible person
Amir Ghorbanihaghjo
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Tabriz, Iran.
City
Tabriz
Postal code
51664
Phone
+98 41 1336 3234
Fax
Email
ghorbaniamir@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir Ghorbanihaghjo
Position
PHD
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences. Medical Faculty
City
Tabriz
Postal code
Phone
+98 41 1336 3234
Fax
Email
ghorbaniamir@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)