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IRCT20160713028901N4 IRCT 2020-11-08 Esfahan University of Medical Sciences The effect of selenium supplementation on lipid profile, anemia and inflammation indices The effect of selenium supplementation on lipid profile, anemia and inflammation indices in patients undergoing peritoneal dialysis: A placebo-controlled clinical trial 2020-10-22 anticipated 90 Complete https://irct.ir/trial/51436 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomization of samples will be based on the block randomization method. Information such as the number of treatment groups (the two main intervention groups for example A and placebo for example B), the size of the blocks (a multiple of the number of groups that will be selected in this study to reduce the complexity of size 4 work) and the total number of patients (sample size 90 (For example, available at https://www.sealedenvelope.com/simple-randomiser/v1/lists) and according to the codes with the final analysis (including the number of specified groups 4). A code will be assigned to each patient entering the study, and the type of group to receive medication or placebo will be determined. Blocking is usually used to balance the number of samples assigned to each of the groups studied. In this method, equal blocking will be used. In this way, the samples are randomized as much as possible in the two groups. At the end of the sampling, the code of each patient is opened and matched with the software output, and as far as possible, the data collector and the intervener try to be informed of the drug code information only after analyzing the data, Blinding description: The placebo will be prepared in Isfahan School of Pharmacy or Amin Pharmaceutical Company (service purchase). The placebo capsule has a similar appearance and is made from common expanses in the production and filling of pharmaceutical supplements; The drug and placebo are placed in the same package by the researcher so that the blinding method can be performed well. Then a small number of placebo and supplement products are provided to the patient, assuming that the entire course is completed with a daily dose and a specific code. The information in this special code on drug packages is only available to the main executor of the project who is not involved in the sampling, and the rest of the project partners do not know if the relevant code is for the drug or placebo. Thus, sampling will be done by blind method. 2-3 Peritoneal Dialysis. Intervention 1: Intervention group: Treated with 200 micrograms alpha brand selenium tablets, every afternoon for 3 consecutive months. Intervention 2: Control group: Treated with placebo tablets daily, for 3 consecutive months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of information
public Shirinsadat Badri
Department of Clinical Pharmacy, School of Pharmacy, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 00 00 badri@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Shirinsadat Badri
Department of Clinical Pharmacy, School of Pharmacy, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 00 +98 31 3792 7068 badri@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients undergoing peritoneal dialysis over 18 years of age At least three months have passed since the first dialysis session Satisfied with the study 18 years no limit Both Having active hepatitis (according to several studies, selenium levels decrease in patients with hepatitis B and C) Normal serum selenium levels Taking steroidal and non-steroidal anti-inflammatory drugs within two months before the start of the study Take selenium supplements within two months of starting the study Insufficient incompatibility to consume the product N 18.6 End stage renal disease Treatment - Drugs Placebo Intervention group: Treated with 200 micrograms alpha brand selenium tablets, every afternoon for 3 consecutive months Control group: Treated with placebo tablets daily, for 3 consecutive months Serum selenium levels. Timepoint: Before the start and after the end of 3 months. Method of measurement: Serum selenium level of patients by atomic electron normal absorption method with graphite furnace using unicam929-uk device made by variant company in USA. Lipid profiles (including total cholesterol, LDL, HDL, and TG). Timepoint: Before the start and after the end of 3 months. Method of measurement: By standard laboratory methods. Indicators associated with anemia. Timepoint: Before the start and after the end of 3 months. Method of measurement: By standard laboratory methods. Iinflammation. Timepoint: Before the start and after the end of 3 months. Method of measurement: By standard laboratory methods. Esfahan University of Medical Sciences Approved 2020-10-03 Isfahan university of medical sciences Hezar-Jerib Isfahan Isfehan Iran (Islamic Republic of)