End stage renal disease (ESRD) is a condition that endothelial dysfunction plays an important role in atherosclerosis. The aim of this study was to investigate the effects of dietary omega-3 fatty acid supplementation on levels of inflammatory markers. We entered 60 patients in the study if they are more than 18 years old , hemodialysis for 3 months and without using omega-3 in 3 months ago. If a patient has chronic diarrhea, malignancy, coagulation disorders or anticoagulation drugs use, excluded from study. Group 1 (30 patients) using omega 3 capsuls, 1000mg, manufactured by Zahravi Pharmaceutical, 3 times a day for 6 months. Group 2 (30 patients) using placebo capsules, manufactured by Zahravi pharmaceutical, 3 times a day for 6 months. Serum level of Q-CRP and TNF-α are measured at begining and 6 months after the study. The relationship between these variables will evaluate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602012417N18
Registration date:2016-09-16, 1395/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-16, 1395/06/26
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
2013-10-23, 1392/08/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Omega-3 supplementation on the inflammatory factors in hemodialysis patients
Public title
Omega-3 and inflammation in hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
at least 18 years old; hemodialysis for at least 3 months; consent for cooperation; without usage of omega-3 during past 3 months
Exclusion criteria:
history of steatorrhea; malignancy; abnormal coagulation profile; need for anticoagulation therapy.
Age
From 18 years old to 99 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences , Hezar Jarib Ave
City
Isfahan
Postal code
Approval date
2014-01-16, 1392/10/26
Ethics committee reference number
293185
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum Q-CRP level
Timepoint
At begining and after 6 months
Method of measurement
ELISA kit, mg/dL
2
Description
Serum TNF-a level
Timepoint
At begining and after 6 months
Method of measurement
ELISA kit, mg/dL
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cap Omega-3 1000mg 3capsule per day for 6 months manufactured by Zahravi company
Category
Treatment - Drugs
2
Description
Control group: Cap placebo for 6 months manufactured by Zahravi company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nour Hospital, Hemodialysis centre
Full name of responsible person
Dr. Yaser Salehi
Street address
Ostandari street, Nour Hospital
City
Isfahan
2
Recruitment center
Name of recruitment center
Alzahra Hospital, Hemodialysis center
Full name of responsible person
Dr. Yaser Salehi
Street address
Sofe street, Alzahra Hospital
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, Isfahan University of Medical Sciences
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. Yaser Salehi
Position
Internal medicine resident
Other areas of specialty/work
Street address
Alzahra Hospital. Sofe Street. Isfahan
City
Isfahan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
Email
dysalehi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mortazavi
Position
Associate professor of Nephrology
Other areas of specialty/work
Street address
Alzahra Hospital. Sofe Street. Isfahan
City
Isfahan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
Email
m_mortazavi@med.mui.ac.ir
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
Assistant Professor of Nephrology
Other areas of specialty/work
Street address
Alzahra Hospital. Sofe street. Isfahan
City
Isfahan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
Email
moinzade@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)