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IRCT20220611055142N1 IRCT 2022-07-07 Tabriz University of Medical Sciences Omega-3 on vascular function in hemodialysis patients The effect of omega-3 fatty acid supplementation on endothelial function in end-stage renal disease: a randomized controlled trial 2022-07-23 anticipated 36 Complete https://irct.ir/trial/64111 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 End stage renal disease (ESRD). Intervention 1: 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). Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All the potential data acquired from the patients after de-identification When: Available just following the publication. To whom: None. Conditions: Every request sent through the editorial board of the publishing journal. Where to obtain: The e-mail of the corresponding author: ali.akhavi.milani@gmail.com How to obtain: The requests submitted to the corresponding author's e-mail will be answered within seven days. Comments:
public Ali Akhavi Milani
Golgasht St
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5921 ali.akhavi.milani@gmail.com Tabriz University of Medical Sciences scientific ‪Mohammadreza Ardalan
Golgasht St
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5921 ardalan34@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with End-stage renal disease undergoing regular hemodialysis 18 years no limit Both Age group under 18 Diagnosed with active infection Diagnosed with severe heart failure Bilaterally Injured cubital vascular anatomy N18.6 End stage renal disease Treatment - Drugs Placebo 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). 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. 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. Tabriz University of Medical Sciences Approved 2022-04-06 ethics committee of Tabriz university of medical sciences Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)