The effect of omega-3 fatty acid plus vitamin E supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Hemodialysis patients
Objective: The aim of this study is to determine the effects of omega-3 fatty acid and vitamin E co-supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Hemodialysis patients. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Patients aged 18-75 years with Hemodialysis status will be included in this study. Receiving omega-3 fatty acid and vitamin E in 3 months prior to the study, pregnancy (positive β-HCG), liver disease and PTH more than 150 pg/ml will be excluded in the study. Population and sample size: 120 Hemodialysis patients eligible and referred to Akhavan Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be divided into four groups to receive either 1200 mg omega-3/day plus 400 IU vitamin E/day co-supplement (intervention group: n=30), 1200 mg omega-3/day supplement (intervention group: n=30), 400 IU vitamin E/day supplement (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention to measure metabolic profiles, inflammatory factors and biomarkers of oxidative stress. Start and End Date of Intervention: 12 weeks (August 1, 2014-November 1, 2014). Outcomes: Fasting plasma glucose, serum triglycerides, cholesterol, HDL-cholesterol, hs-CRP levels, nitric oxide, plasma total antioxidant capacity (TAC), total glutathione (GSH) and malondialdehyde (MDA) will be measured at baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410245623N28
Registration date:2014-10-26, 1393/08/04
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-10-26, 1393/08/04
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-07-22, 1393/04/31
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 fatty acid plus vitamin E supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Hemodialysis patients
Public title
Effect of supplementation in treatment of Hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients aged 18-75 years with Hemodialysis status.
Exclusion Criteria: Receiving omega-3 fatty acid and vitamin E in 3 months prior to the study; pregnancy (positive β-HCG); liver disease; PTH more than 150 pg/ml.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2014-08-01, 1393/05/10
Ethics committee reference number
P/29/5/1/3538
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
3
Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
4
Description
HDL-cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
5
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
6
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
7
Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
8
Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Omega-3 pearl and vitamin E pearl, 1200 mg and 400 IU, daily, for 12 weeks orally.