]>
IRCT20170513033941N62 IRCT 2019-08-03 Islamic Azad University Selenium supplementation in the treatment of hemodialysis patients Investigation of the effect of selenium supplementation on gene expression levels associated with insulin, lipid and inflammatory metabolism in diabetic hemodialysis patients 2019-07-09 anticipated 40 Complete https://irct.ir/trial/41204 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 40 by SPSS software and participants will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes, 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, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded. 3 Hemodialysis. Intervention 1: Intervention group: Selenium supplements (Nature, California, USA), 200 µg, daily, for 24 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 24 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 1771844351 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 1771844351 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Diabetic hemodialysis patients aged 45 to 75 years. 45 years 75 years Both Patients taking antioxidant and/or anti-inflammatory supplements within 3 months prior to intervention Patients with infectious diseases Patients with malignant diseases N18.6 End stage renal disease Treatment - Drugs Placebo Intervention group: Selenium supplements (Nature, California, USA), 200 µg, daily, for 24 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 24 weeks orally. Expressed levels of PPAR-γ gene. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of TNF gene. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of VEGF gene. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of TGF-β gene. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of IL-1 gene. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: RT-PCR. Expressed levels of LDL-ox gene. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: RT-PCR. Islamic Azad University Approved 2019-07-08 Ethics committee of Islamic Azad University-Yazd Branch Shahid Gomnam Boulevard, Yazd Yazd Yazd Iran (Islamic Republic of)