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Effect of omega-3 supplementation on inflammatory parameters in patients on chronic ambulatory peritoneal dialysis

Protocol summary

Summary
End stage renal disease (ESRD) is a condition that inflammation plays an important role in damaging to tissues, especially in vascular system. The effect of omega-3 fatty acids is well documented in some inflammatory diseases via eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) components of fish oil. The aim of this study was to investigate the effects of dietary omega-3 fatty acid supplementation on levels of inflammatory parameters in ESRD patients. In this study, 40 patients with 18 years old, at least, arrived if they are on chronic ambulatory peritoneal dialysis for 3 months. If patient have chronic diarrhea, malignancy, thrombocytopenia(less than 100000/mm3, coagulation disorders, need to anticoagulant drugs exclude from study. Group 1 (20 patients) using omega 3 capsules, 1000mg, manufactured by Zahravi Pharmaceutical, 3 times a day for 2 months. Group 2 (20 patients) using placebo capsules, manufactured by Zahravi pharmaceutical, 3 times a day for 2 months. Serum level of Interlukin-6 and C-reactive protein(CRP) are measured at beginning and end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201303052417N11
Registration date: 2013-06-12, 1392/03/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-11-02, 1391/08/12
Expected recruitment end date
2013-01-01, 1391/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega-3 supplementation on inflammatory parameters in patients on chronic ambulatory peritoneal dialysis
Public title
Effect of omega-3 supplementation on inflammatory parameters in patients on chronic ambulatory peritoneal dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 1- age more than 18 years old. 2- peritoneal dialysis for 3 months at least. Exclusion criteria: 1- history of malignancy. 2- steatorhea. 3- thrombocytopenia (platelet less than 100000/mm3). 4- coagulopathy. 5- anticoagulation therapy.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
hezar jarib street
City
Isfahan
Postal code
Approval date
2012-10-31, 1391/08/10
Ethics committee reference number
391350

Health conditions studied

1

Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End Stage Renal Disease

Primary outcomes

1

Description
Serum Interlukin-6 level
Timepoint
Begining of the study, after 2 months
Method of measurement
ELISA Kit pg/mL

2

Description
Serum CRP level
Timepoint
Begining of the study, after 2 months
Method of measurement
ELISA Kit, mg/L

Secondary outcomes

empty

Intervention groups

1

Description
Cap Omega-3 1000mg 3capsule per day for 2 months manufactured by Zahravi company
Category
Treatment - Drugs

2

Description
Cap placebo for 2 months manufactured by Zahravi company
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital, Peritoneal dialysis centre
Full name of responsible person
Shirin Karimi
Street address
Sofe street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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
University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
Fellowship of NephrologyIsfahan
Other areas of specialty/work
Street address
Sofe Street, Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
moinzade@resident.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Afsoon Emami Naeini
Position
Assistant Proff of Nephrology
Other areas of specialty/work
Street address
Ostandari Street, Nour hospital
City
Isfahan
Postal code
Phone
+98 31 1222 2127
Fax
Email
emaminaini_afsoon@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
fellowship of Nephrology
Other areas of specialty/work
Street address
Hezar jerib street
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
moinzade@resident.mui.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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