Effect of Omega-3 therapy on the serum level of Homocysteine in peritoneal dialysis patients

The aim of this study is to investigate several parameters related to oxidative stress and systemic inflammation, especially homocysteine in peritoneal dialysis patients receiving omega-3 fatty acids.

A concealed, randomized, blinded, sham-controlled clinical trial with a parallel-group design of 100 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 omega-3 soft capsule intervention group will receive one gram with each meal for 8 weeks. Participants in the control group will receive a placebo. Serum lipid profile, serum albumin level, ESR level, hs-CRP level and serum homocysteine ​​level were measured in all patients before the start of the study and after 8 weeks at the end of the study. Finally, using statistical tests, the average of the measured tests will be compared between the two groups. Researchers and patients are blinded

Inclusion criteria: age 18 years and older, ESRD patients undergoing peritoneal dialysis, informed consent to participate in this study Exclusion criteria: history of malignancy, patients with a history of known allergies to products containing omega-3, coagulation disorders and use of anticoagulants, use of any antioxidant or anti-inflammatory drugs, severe systemic diseases or infectious diseases

For the intervention group omega-3 capsules (120 mg DHA plus 180 mg EPA) at a dose of 3000 mg per day, ie 1000 mg with each meal per day for 8 weeks will be prescribed and the control group will receive a placebo.

Homocysteine levels and inflammatory and oxidative markers

In this study, the basis of randomization of samples will be based on the Blocked 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 ( Enter the sample size of 100 people) into the Internet software for this calculation (for example, available at https://www.sealedenvelope.com/simple-randomiser/v1/lists) and according to the codes with the final analysis is obtained, a code is assigned to each patient who enters the study, and the type of group that should take 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 both 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 intervener try to be informed of the drug code information only after analyzing the data.

Due to the nature of soft gelatin, preparation of placebo related to omega-3 capsules cannot be done in Isfahan School of Pharmacy and will be done in coordination with Zahravi Company in that factory. According to the company's pharmaceutical experts, edible vegetable oils that do not contain linoleic acid are used to make placebo. Also, the main omega-3 product containing each capsule (EPA equivalent of 180 mg and ‌ equivalent of 120 mg) is prepared from the same factory so that the drug and placebo are in the same package and the blinding method can be performed well. Then a small number of placebo and supplement products for a patient, provided they complete the entire course with a dose of three times a day and a special code, are provided to the student. 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 the blind method.

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