Evaluating the effect of Omega-3 supplementation on endothelial function in patients with end-stage renal disease.
Design
Randomized, superiority, parallel-group trial with blinded outcome assessment. Randomization was centralized and computerized with concealed randomization sequence carried out at an external site
Settings and conduct
This study will be conducted in the hemodialysis ward of a university-affiliated tertiary care center. After recruiting the patients based on the inclusion and exclusion criteria, the baseline numerical value of flow-mediated vasodilation will be measured in all these patients (by an experienced sonographer). Patients will be randomly allocated into two groups. One group will receive omega-3 supplements and the second group will receive a placebo (double-blind). Following the treatment period, the measurement of flow-mediated vasodilation will be repeated for both groups. The difference observed in the flow-mediated vasodilation variable between the two groups will be assessed and compared.
Participants/Inclusion and exclusion criteria
Known cases of end-stage renal disease (ESRD) will be included in the study. Patients under 18, patients with active infection, patients with severe heart failure, and patients in whom the vascular anatomy of the cubital area is bilaterally injured will be excluded.
Intervention groups
One group of patients will receive Omega-3 supplementation, and the second group will receive a placebo.
Main outcome variables
The numerical value of the flow-mediated vasodilation which is calculated using the sonography machine based on percentage. This will be a continuous variable.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220611055142N1
Registration date:2022-07-07, 1401/04/16
Registration timing:prospective
Last update:2022-07-07, 1401/04/16
Update count:0
Registration date
2022-07-07, 1401/04/16
Registrant information
Name
Ali اخوی میلانی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3442 8855
Email address
ali.akhavi.milani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 fatty acid supplementation on endothelial function in end-stage renal disease: a randomized controlled trial
Public title
Omega-3 on vascular function in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with End-stage renal disease undergoing regular hemodialysis
Exclusion criteria:
Age group under 18
Diagnosed with active infection
Diagnosed with severe heart failure
Bilaterally Injured cubital vascular anatomy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used. Patients (36 patients) will be numbered based on the date of their visit. Subsequently, 36 numbers will be written on 36 cards from 1 to 36 and then 18 cards will be randomly selected and these numbers will be placed in the intervention group and will receive omega-3. The remainder of the patients will be placed in the control group and will receive a placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
Neither the patients nor the caregiver who will give the medicines to the patients will be unaware of the type of the medicines. The sonographer who will calculate the vascular diameters will also be unaware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tabriz university of medical sciences
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5177658847
Approval date
2022-04-06, 1401/01/17
Ethics committee reference number
IR.TBZMED.REC.1401.056
Health conditions studied
1
Description of health condition studied
End stage renal disease (ESRD)
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
The numerical value of flow-mediated vasodilation which is calculated using sonography machine based on percentage.
Timepoint
Calculation of flow-mediated vasodilation, once in the beginning of the study (baseline values before initiation of the treatment), and subsequently, three weeks following the continuation of Omega-3 supplementation.
Method of measurement
The numerical number will be calculated using sonography machine.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pearl Omega-3 1000 mg (Zahravi Pharmaceutical Company) daily for 3 weeks will be prescribed to the patients in the intervention group. The usage method will be elucidated to the patient upon administration and the usage correctness will be assured on each visit of the patients to the hemodialysis ward (these patients usually visit the hemodialysis ward three days a week).
Category
Treatment - Drugs
2
Description
Control group: Placebo pearls with identical physical appearance manufactured by the same pharmaceutical company (Zahravi) will be prescribed to be taken daily for three weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ali Akhavi Milani
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Fax
Email
dabirkhanecent@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
dabirkhanecent@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Akhavi Milani
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
ali.akhavi.milani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
ardalan34@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Akhavi Milani
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
ali.akhavi.milani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the potential data acquired from the patients after de-identification
When the data will become available and for how long
Available just following the publication.
To whom data/document is available
None.
Under which criteria data/document could be used
Every request sent through the editorial board of the publishing journal.
From where data/document is obtainable
The e-mail of the corresponding author: ali.akhavi.milani@gmail.com
What processes are involved for a request to access data/document
The requests submitted to the corresponding author's e-mail will be answered within seven days.