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Effects of omega-3 fatty acid supplementation on metabolic profiles, hs-CRP and biomarkers of oxidative stress in diabetic nephropaty patients

 View older revisions Content changed at 2019-09-16, 1398/06/25

Protocol summary

Study aim
The aim of this study is to determine the effects of omega-3 fatty acid supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in diabetic nephropathy patients.
Design
Randomized, double-blind, placebo-controlled clinical trial, phase 2, 60 patients
Settings and conduct
60 patients with diabetic nephropathy of eligible and referred to Akhavan Clinic, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients with diabetic nephropathy with a proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels and aged 45 to 85 years will be included in this study. Exclusion criteria: the intake of omega-3 fatty acid supplements within 3 months, patients with uncontrolled diabetes, the current use of warfarin, malignancy and/or liver cirrhosis.
Intervention groups
Patients will be assigned to receive either omega-3 fatty acid (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Metabolic profiles, inflammatory factor and biomarkers of oxidative stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201502255623N36
Registration date: 2015-03-10, 1393/12/19
Registration timing: prospective

Last update: 2019-09-16, 1398/06/25
Update count: 1
Registration date
2015-03-10, 1393/12/19
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
2015-03-11, 1393/12/20
Expected recruitment end date
2015-03-15, 1393/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of omega-3 fatty acid supplementation on metabolic profiles, hs-CRP and biomarkers of oxidative stress in diabetic nephropaty patients
Public title
Effects omega-3 fatty acid supplementation in the treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic nephropathy aged 45 to 85 years. Proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels
Exclusion criteria:
The intake of omega-3 fatty acid supplements within 3 months Patients with uncontrolled diabetes The current use of warfarin Malignancy and/or liver cirrhosis.
Age
From 45 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either omega-3 fatty acid supplement or placebo. Randomization will be done by the use of Stat Trek software. https://stattrek.com/statistics/random-number-generator.aspx
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Akhavan Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
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
Province
Isfehan
Postal code
8715981151
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
93211

Health conditions studied

1

Description of health condition studied
Diabetic nephropathy
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Insulin resistance
Timepoint
Baseline and End-of-trial
Method of measurement
Calculation using HOMA formula

2

Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
ELISA kit

Secondary outcomes

1

Description
High-sensitivity C-reactive protein
Timepoint
Baseline and End-of-trial
Method of measurement
ELISA test

2

Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

3

Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

4

Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

5

Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

6

Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

7

Description
Total cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

8

Description
HDL
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

9

Description
Fasting blood sugar
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

10

Description
LDL
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

11

Description
Blood Urea Nitrogen
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

12

Description
Serum Creatinine
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

Intervention groups

1

Description
Intervention group: Omega-3 fatty acid pearl, 1000 mg, daily, for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo pearl, daily, for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhavan Clinic
Full name of responsible person
Alireza Soleimani
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
soleimani_a@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
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

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

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
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