Protocol summary
-
Study aim
-
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.
-
Design
-
Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers.
-
Settings and conduct
-
Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 120 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
-
Participants/Inclusion and exclusion criteria
-
Inclusion Criteria: Patients aged 18-80 years with Hemodialysis status. Exclusion Criteria: Pregnant, taking antioxidant supplements or immunosuppressive medications within 3 months prior to enrollment.
-
Intervention groups
-
Intervention group: Omega-3 pearl and vitamin E pearl, 1250 mg and 400 IU, daily, for 12 weeks orally.
Intervention group: Omega-3 pearl, 1250 mg, daily, for 12 weeks orally.
Intervention group: Vitamin E pearl, 400 IU, daily, for 12 weeks orally.
Control group: Placebo pearl, daily, for 12 weeks orally.
-
Main outcome variables
-
Outcomes: Malondialdehyde and SGA score (primary outcomes), and glycemic control, lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
-
Reason for update
-
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201410245623N28
Registration date:
2014-10-26, 1393/08/04
Registration timing:
retrospective
Last update:
2019-11-03, 1398/08/12
Update count:
1
-
Registration date
-
2014-10-26, 1393/08/04
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Kashan University of Medical Sciences
-
Expected recruitment start date
-
2014-08-02, 1393/05/11
-
Expected recruitment end date
-
2014-08-06, 1393/05/15
-
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 18-80 years with Hemodialysis status
Exclusion criteria:
Pregnant
Taking antioxidant supplements or immunosuppressive medications within 3 months prior to enrollment
-
Age
-
From 18 years old to 80 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
120
-
Randomization (investigator's opinion)
-
Not randomized
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
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
-
SGA score
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Calculation
2
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
Secondary outcomes
1
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
2
-
Description
-
Insulin resistance
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Calculation using HOMA formula
3
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
4
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
5
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
6
-
Description
-
LDL
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
7
-
Description
-
VLDL
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
8
-
Description
-
FPG
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
9
-
Description
-
Total antioxidant
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
10
-
Description
-
Glutathione
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
11
-
Description
-
Nitric oxide
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
12
-
Description
-
Hs-CRP
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
13
-
Description
-
Creatinine
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
14
-
Description
-
BUN
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
15
-
Description
-
Albumin
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
16
-
Description
-
TIBC
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
Intervention groups
1
-
Description
-
Intervention group: Omega-3 pearl and vitamin E pearl, 1250 mg and 400 IU, daily, for 12 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention group: Omega-3 pearl, 1250 mg, daily, for 12 weeks orally.
-
Category
-
Treatment - Drugs
3
-
Description
-
Intervention group: Vitamin E pearl, 400 IU, daily, for 12 weeks orally.
-
Category
-
Treatment - Drugs
4
-
Description
-
Control group: Placebo pearl, daily, for 12 weeks orally.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kashan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available