In this double-blind randomized clinical trial, 60 patients with type 2 and 1 diabetic nephropathy who referred to the Rasoul-akram clinic were selected by convenience sampling method and randomly assigned into control and intervention groups.
A questionnaire containing demographic information of patients at the time of enrollment is completed. Both groups are matched in terms of receiving conventional treatment and HbA1C level.
Patients in the intervention group receive conventional treatments and omega-3 capsules and in the control group receive conventional and placebo treatments. Random blood and urine samples of patients are collected to measure the urinary creatinine-to-albumin ratio, and the ratio, protein-to-creatinine ratio, GFR, and serum levels of creatinine, albumin, urea.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with type 1 and type 2 diabetic nephropathy and glomerular purification rate more than 60 ml / min and over 21 years of age
Exclusion criteria: Uncontrolled hypertension, hyperlipidemia, urinary tract infection and heart failure, dose adjustment of drugs, warfarin use, allergy or omega-3 intolerance
Intervention groups
Patients in the intervention group would receive conventional treatments and omega-3 capsules (1000 mg daily for 12 weeks) and the placebo group receive conventional treatment and placebo (continued for 12 weeks).
Main outcome variables
Creatinine and blood urea; urinary creatinine and albumin; blood pressure ; glomerular filtration rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220301054158N1
Registration date:2023-03-09, 1401/12/18
Registration timing:retrospective
Last update:2023-03-09, 1401/12/18
Update count:0
Registration date
2023-03-09, 1401/12/18
Registrant information
Name
Fatemeh Ghasemi Korani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 004 5793
Email address
fatemehghasemi2015@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 supplementation on renal biomarkers in patients with diabetic nephropathy
Public title
The effect of omega-3 supplementation on renal biomarkers in patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 1 and type 2 diabetic nephropathy
Fasting blood sugar more than 126 mg/ dl and/ or taking glucose-lowering drugs or insulin
Proteinuria is more than 300 mg per day
Glomerular filtration rate more than 60 ml per minute
Minimum 21 years of age
Exclusion criteria:
Uncontrolled hypertension
Hyperlipidemia
Urinary tract infection
Heart failure
Changing the dose of medication
Taking warfarin
Allergies or omega-3 intolerance
Age
From 21 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling of patients will be available as two groups are blocked by random allocation method and two groups of 30 people are formed with the help of software
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and physicians are unaware that omega-3s are a drug or a placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Building No. 2, University Headquarters Campus, Kashani Blvd.,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.SKUMS.REC.1400.112
Health conditions studied
1
Description of health condition studied
Diabetic nephropathy
ICD-10 code
E08.21
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic nephropathy;
Primary outcomes
1
Description
Blood creatinine level
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
High-performance liquid chromatography
2
Description
Blood urea level
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Enzyme assay
3
Description
Urine creatinine
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
High-performance liquid chromatography
4
Description
Urine Albumin
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
BCG (Bromocresol Green) Albumin Assay Kit
5
Description
Blood pressure
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Manometer
6
Description
Glomerular filtration rate
Timepoint
Before the intervention and 12 weeks after the intervention
Method of measurement
Using the CKD-EPI formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Conventional treatment and omega-3
Category
Treatment - Drugs
2
Description
Control group: Conventional treatment and placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-Rasoul Clinic
Full name of responsible person
Fatemeh Ghasemi
Street address
Hazrat Rasool Clinic, Molavi St.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
fatemehghasemi2015@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
دکتر اسفندیار حیدریان
Street address
Building No. 2, University Headquarters Campus, Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
fatemehghasemi2015@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Fatemeh Ghasemi Korani
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
1st floor, 72nd alley, West Sa'di Ave
City
Shaherkord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 913 004 5793
Fax
Email
fatemehghasemi2015@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Parisa Javadian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Shahrekord, Parstar St.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
javadian.p@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fatemeh Ghasemi Korani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Corner of 72nd alley, West Saadi Ave
City
Shaherkord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881763617
Phone
+98 913 004 5793
Fax
Email
fatemehghasemi2015@yahoo.com
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