The effect of selenium supplementation on lipid profile, anemia and inflammation indices in patients undergoing peritoneal dialysis: A placebo-controlled clinical trial

The aim of this study was to evaluate the effect of selenium supplementation on lipid profile, anemia and inflammation parameters in patients undergoing peritoneal dialysis.

A concealed, randomized, blinded, sham-controlled clinical trial with a parallel-group design of 90 patients, block randomization was used for randomization

Individuals who meet the inclusion criteria will be randomly assigned to the intervention and control groups. Demographic and clinical characteristics of patients will be recorded. Patients in the intervention group will receive 200 micrograms of selenium tablets daily for 3 months. Participants in the control group will receive a placebo. At the end of 3 months, serum selenium levels and lipid profiles and indicators related to anemia and inflammation are measured and recorded again. Finally, using statistical tests, the average of the measured tests will be compared between the two groups. Researchers involved in sampling and blinded patients.

Inclusion criteria: Patients under peritoneal dialysis over 18 years old; At least three months have passed since the first dialysis. Be satisfied with the study. Exclusion criteria: Having active hepatitis. 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

The intervention group was treated with 200 micrograms of selenium tablets daily and the control group was treated daily with placebo for 3 months.

Serum selenium levels and fat profiles and indicators associated with anemia and inflammation

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.

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.

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