Evaluation of the effect of omega-3 supplimentation on serum lipid in patients with chronic dialysis
Objectives:
This study has been done to examine the complementary effects of omega lipid on High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglyceride (TG) and Cross reacting Protein (CRP) profile serums In Patients with chronic hemodialysis.
Design:
This clinical trial will be done randomly and double blind with using placebo. They will be chosen from among the patients called on hemodialysis unit of Ardabil BUALI Hospital.
Setting and Conduct:
Patients will be grouped in two intervention and control groups. Intervention group will receive one omega 3 Capsule and control group will receive one placebo capsule for three months. Study indexes will be measured before and after intervention in laboratory.
Major Inclusion and Exclusion Criteria:
This intervention will include patients with following conditions:
1. Patients that have been received dialysis therapy for more than three months.
2. Patients that have been received no anti-lipid drugs as yet.
Patients that can’t tolerate drugs receive or not interested in drugs receive or die during intervention will exclude from intervention.
Intervention:
In used intervention we will prescribe omega Max Capsule to 30 patients of intervention group and placebo capsule to 30 patients of control group. We will do intervention from 06.12.2014 until 20.03.2015.
Main outcome measures variables:
Main outcome measures variables are TG، HDL and LDL that will be studied before and after of interval.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014112520087N1
Registration date:2015-05-24, 1394/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-24, 1394/03/03
Registrant information
Name
Elnaz Khodaei Ardabili
Name of organization / entity
Ardabil University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 9580
Email address
elnaz.khodaei@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Ardabil University Of Medical Sciences
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of omega-3 supplimentation on serum lipid in patients with chronic dialysis
Public title
Examine the complementary effects of omega lipid on lipid profile serum and compare it with effect of placebo of omega in patients With Chronic dialysis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients that have been receive dialysis therapy for more than three months؛ patients that have been received no anti-lipid drugs as yet.
Exclusion criteria for the study: Patients that can’t tolerate drugs receive؛ patients not interested in drugs receive؛ patients die during intervention.
Age
No age limit
Gender
Both
Phase
N/A
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
Patients of omega and placebo groups will be selected randomly. Omega group patients will select among patients dialysis on Saturday, Monday and Wednesday and placebo group patients will select among patients dialysis on Sunday, Tuesday and Thursday.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University Of Medical Sciences
Street address
Ardabil University Of Medical Sciences, Daneshgah Street.
City
Ardabil
Postal code
56198-53141
Approval date
2014-07-27, 1393/05/05
Ethics committee reference number
93.48.Arums.REC
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
High Density Lipoprotein (HDL)
Timepoint
Before and three months after intervention
Method of measurement
Laboratory measurement of serum HDL concentrations in scale mili mol / lit
2
Description
Low Density Lipoprotein (lDL)
Timepoint
Before and three months after intervention
Method of measurement
Laboratory measurement of serum LDL concentrations in scale mili mol / lit
3
Description
Triglyceride(TG)
Timepoint
Before and three months after intervention
Method of measurement
Laboratory measurement of serum TG concentrations in scale mili mol / lit
Secondary outcomes
1
Description
Cross Reacting Protein (CRP)
Timepoint
Before intervention, three months after intervention
Method of measurement
Laboratory measurement of serum CRP concentrations in scale Mg / dl
Intervention groups
1
Description
Control:
Daily one placebo of Omega Max made in Zahravi Pharmaceutical Company for three months Prescribed.
Category
Placebo
2
Description
Intervention group:
Daily one Omega Max Capsule made in Zahravi Pharmaceutical Company containing 400 mg Eicosapentanoic Acid and 300 mg Decosa Hexanoic Acid for three months prescribed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Unit, Ardabil Buali Hospital.
Full name of responsible person
Hemodialysis Unit supervisor, MA.Nursing, Rita Shamshiri
Street address
Hemodialysis Unit, Ardabil Buali Hospital, Moallem Street.
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller for research of Ardabil University of Medical Sciences
Full name of responsible person
Dr. Shahram Habibzadeh
Street address
Vice Chanceller for research of Ardabil University of Medical Sciences, kowsar town
City
Ardabil
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller for research of Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Bahman Bashardoost
Position
Nephrologiest, faculty members of medical sciences