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The effect of omega-3 fatty acid supplementation on oxidative stress in continuous ambulatory peritoneal dialysis patients

Protocol summary

Summary
End stage renal disease (ESRD) is a condition that inflammation and oxidative stress 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 lipid peroxidation and oxidative sttress in ESRD patients. In this study, 90 patients arrived if they are on chronic ambulatory peritoneal dialysis for 3 months, clinically stable without serious disease and in stage 1 hypertension. If patient have chronic diarrhea, malignancy, thrombocytopenia(less than 100000/mm3, coagulation disorders, need to anticoagulant drugs or psychosomatic disorders exclude from study. Group 1 (45 patients) using omega 3 capsuls, 1000mg, manufactured by Zahravi Pharmaceutical, 3 times a day for 6 weeks. Group 2 (45 patients) using placebo capsules, manufactured by Zahravi pharmaceutical, 3 times a day for 6 weeks. Serum level of reduced gluthation and superoxid dismutase are measured at begining and end of the study so iron, ferritin, lipid profile. Erythropoietin requirement is measured at begining and end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201212142417N10
Registration date: 2012-12-27, 1391/10/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-27, 1391/10/07
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
2012-04-28, 1391/02/09
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 fatty acid supplementation on oxidative stress in continuous ambulatory peritoneal dialysis patients
Public title
The effect of omega-3 fatty acid supplementation on oxidative stress in continuous ambulatory peritoneal dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1)Clinically stable patients without serious disease. 2)continuous ambulatory peritoneal dialysis (CAPD) for at least 3 months. 3)hypertension stage 1(according to JNC VII) or under treatment. Exclusion criteria: 1)history of steatorrhea. 2) malignancy. 3) thrombocytopenia (PLT<100000/mm3). 4) abnormal coagulation profile. 5)need for anticoagulation therapy. 6)psychosomatic disorders.
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
2012-04-23, 1391/02/04
Ethics committee reference number
290370

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
Reduced gluthation
Timepoint
Begining of the study, after 6 weeks
Method of measurement
ELISA kit, U/mL

2

Description
Srum superoxide dismutase
Timepoint
Begining of the study, after 6 weeks
Method of measurement
ELISA kit, U/mL

Secondary outcomes

1

Description
Serum Iron
Timepoint
Begining of the study, after 6 weeks
Method of measurement
ELISA kit, mg/dL

2

Description
Serum ferritin
Timepoint
Begining of the study, after 6 weeks
Method of measurement
ELISA kit, mg/dL

3

Description
Low density lipoprotein(LDL)
Timepoint
Begining of the study, after 6 weeks
Method of measurement
mg/dL

4

Description
High density lipoprotein (HDL)
Timepoint
Begining of the study, after 6 weeks
Method of measurement
mg/dL

5

Description
Triglyceride
Timepoint
Begining of the study, after 6 weeks
Method of measurement
mg/dL

6

Description
Cholesterol
Timepoint
Begining of the study, after 6 weeks
Method of measurement
mg/dL

Intervention groups

1

Description
Cap Omega-3 1000mg 3capsule per day for 6 weeks manufactured by Zahravi company
Category
Treatment - Drugs

2

Description
Cap placebofor 6 weeks 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

2

Recruitment center
Name of recruitment center
Nour Hospital, Peritoneal Dialysis centre
Full name of responsible person
Dr Fsoon Emami Naini
Street address
Ostandari 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
Fellowship of Nephrology
Other areas of specialty/work
Street address
Sofe Street, Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1668 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
Sofe street, Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
fimoinzad@yahoo.commoinzade@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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