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IRCT20151226025699N6 IRCT 2022-12-24 Rasht University of Medical Sciences Investigating the effect of omega-3 supplementation on inflammatory indices of dialysis patients The Effect of Omega-3 Supplementation on Inflammatory Clinical Markers and Body Composition in Hemodialysis Patients A randomized, triple-blind, placebo- controlled trial 2022-11-06 anticipated 120 Complete https://irct.ir/trial/66638 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of people to study groups (test and control) was done by random block method and using WinPepi11.0 software (http://www.brixtonhealth.com/pepi4windows.html). This software generates random groups. The output of the software is in the form of six blocks of numbers, in each block 3 people belong to the control group and 3 people belong to the intervention group, and the software itself randomly arranges the blocks. Finally, 16 blocks were used and the samples are entered into the study in order. The steps of using the mentioned software were as follows: ETCETERA, choose Random allocation (Randomization), then choose Balanced Randomization, and finally Successive blocks. A member of the research team not involved in the selection of samples will determine the sequence of random allocation using a computer program. Randomly sequenced opaque sealed envelopes will be used to conceal the allocation, Blinding description: This research is done in a triple-blind way. In this way, the patient, the researcher, and the statistical analyst are not aware of the study arms. The patient is blinded by providing a placebo similar in shape and appearance to the drug in the intervention group. Project researchers do not know the groups of people when taking questionnaires and tests from the participants before and after the intervention. Someone outside the treatment team also does the evaluation of the results; In such a way that the evaluator researchers are not aware of the type of allocation. 3 Patients with chronic kidney failure undergoing hemodialysis. Intervention 1: Intervention group: Omega-3 capsule contains 1000 mg of fish oil, 180 mg of EPA and 120 mg of DHA and auxiliary components of gelatin, glycerin, sodium methylparaben, sodium propylparaben. Three capsules of omega-3 fatty acids supplement by Zahrawi company are given orally daily for 2 months to patients in the intervention group. The two groups are matched in terms of their dietary intake of omega-3 fatty acids. In order to prevent the abuse of supplements and follow up the process of drug consumption, the drugs will be given to the patients in the form of 21 packs on a weekly basis, and the method of taking the supplements will be followed up by the project colleagues on a weekly basis in person or by phone. Patients are contacted regularly (once a week) in order to prevent participants from withdrawing from the study, controlling drug use or non-use of other supplements, the occurrence of an incident affecting the study, as well as the absence of side effects or gastrointestinal symptoms in the participants. And if any of the above cases exist, the necessary actions and follow-ups will be carried out by the project researchers. Also, the research colleagues talked with the participants about the possible benefits of the study and encouraged them to continue the study. In addition to these cases, the supplements were delivered to the participants in eight 21 times at the Caspian center and they were asked to return the previously used envelopes. This allows researchers to measure adherence to treatment to some extent. After the completion of two months, in order to obtain post-test data and follow-up; The participants will be contacted again and will be invited and encouraged to complete the questionnaires and perform the tests. Intervention 2: Control group: Placebo is completely similar to the probiotic supplement in terms of shape, color, size and packaging, even fillers or auxiliary materials (gelatin, glycerin, sodium methylparaben, sodium propylparaben) and the only difference is the absence of eicosapentaenoic acid and docosahexaenoic acid. The acid is in the placebo. Three placebo capsules containing MCT oil (medium-chain triglyceride) of Zahrawi company, similar to the supplemental dose of the intervention group, are given during this period. The two groups are matched in terms of their dietary intake of omega-3 fatty acids. In order to prevent the abuse of supplements and follow up the process of drug consumption, the drugs will be given to the patients in the form of 21 packs on a weekly basis, and the method of taking the supplements will be followed up by the project colleagues on a weekly basis in person or by phone. Patients are contacted regularly (once a week) in order to prevent participants from withdrawing from the study, controlling drug use or non-use of other supplements, the occurrence of an incident affecting the study, as well as the absence of side effects or gastrointestinal symptoms in the participants. And if any of the above cases exist, the necessary actions and follow-ups will be carried out by the project researchers. Also, the research colleagues talked with the participants about the possible benefits of the study and encouraged them to continue the study. In addition to these cases, the supplements were delivered to the participants in eight 21 times at the Caspian center and they were asked to return the previously used envelopes. This allows researchers to measure adherence to treatment to some extent. After the completion of two months, in order to obtain post-test data and follow-up; The participants will be contacted again and will be invited and encouraged to complete the questionnaires and perform the tests. Yes - There is a plan to make this available What will be shared: A part of the data, such as information related to the main outcome or the like, can be shared after de-identifying people with the coordination of the responsible author. When: - To whom: Researchers working in academic and scientific institutions Conditions: Correspondence with the corresponding author provides further information Where to obtain: sdoaee@yahoo.com How to obtain: - Comments:
public Saeid Doaei
National Nutrition and Food Technology Research Institute, Farahzadi St.
Tehran Iran (Islamic Republic of) 4532166542 +98 21 6643 6744 sdoaei@sbmu.ac.ir Tehran University of Medical Sciences scientific Haider Ali Baloo
Rasht Rasht - Elkhebal Street (Haji Abad) - Corner of Towaf Alley - Baath Specialist and Subspecialty Clinic
Rasht Iran (Islamic Republic of) 4735166734 +98 13 3326 1446 Balou@sbmu.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Written consent Age over 20 years 20 years no limit Both No tendency to participate in the study Having incomplete medical records Consumption of omega-3 fatty acids supplementation during the last 3-month before the study N18 Chronic kidney disease (CKD) Treatment - Drugs Placebo Intervention group: Omega-3 capsule contains 1000 mg of fish oil, 180 mg of EPA and 120 mg of DHA and auxiliary components of gelatin, glycerin, sodium methylparaben, sodium propylparaben. Three capsules of omega-3 fatty acids supplement by Zahrawi company are given orally daily for 2 months to patients in the intervention group. The two groups are matched in terms of their dietary intake of omega-3 fatty acids. In order to prevent the abuse of supplements and follow up the process of drug consumption, the drugs will be given to the patients in the form of 21 packs on a weekly basis, and the method of taking the supplements will be followed up by the project colleagues on a weekly basis in person or by phone. Patients are contacted regularly (once a week) in order to prevent participants from withdrawing from the study, controlling drug use or non-use of other supplements, the occurrence of an incident affecting the study, as well as the absence of side effects or gastrointestinal symptoms in the participants. And if any of the above cases exist, the necessary actions and follow-ups will be carried out by the project researchers. Also, the research colleagues talked with the participants about the possible benefits of the study and encouraged them to continue the study. In addition to these cases, the supplements were delivered to the participants in eight 21 times at the Caspian center and they were asked to return the previously used envelopes. This allows researchers to measure adherence to treatment to some extent. After the completion of two months, in order to obtain post-test data and follow-up; The participants will be contacted again and will be invited and encouraged to complete the questionnaires and perform the tests. Control group: Placebo is completely similar to the probiotic supplement in terms of shape, color, size and packaging, even fillers or auxiliary materials (gelatin, glycerin, sodium methylparaben, sodium propylparaben) and the only difference is the absence of eicosapentaenoic acid and docosahexaenoic acid. The acid is in the placebo. Three placebo capsules containing MCT oil (medium-chain triglyceride) of Zahrawi company, similar to the supplemental dose of the intervention group, are given during this period. The two groups are matched in terms of their dietary intake of omega-3 fatty acids. In order to prevent the abuse of supplements and follow up the process of drug consumption, the drugs will be given to the patients in the form of 21 packs on a weekly basis, and the method of taking the supplements will be followed up by the project colleagues on a weekly basis in person or by phone. Patients are contacted regularly (once a week) in order to prevent participants from withdrawing from the study, controlling drug use or non-use of other supplements, the occurrence of an incident affecting the study, as well as the absence of side effects or gastrointestinal symptoms in the participants. And if any of the above cases exist, the necessary actions and follow-ups will be carried out by the project researchers. Also, the research colleagues talked with the participants about the possible benefits of the study and encouraged them to continue the study. In addition to these cases, the supplements were delivered to the participants in eight 21 times at the Caspian center and they were asked to return the previously used envelopes. This allows researchers to measure adherence to treatment to some extent. After the completion of two months, in order to obtain post-test data and follow-up; The participants will be contacted again and will be invited and encouraged to complete the questionnaires and perform the tests. Body fat percentage. Timepoint: Before the intervention, after the intervention. Method of measurement: It is calculated with a bio-impedance analyzer (BIA). Dialysis itching. Timepoint: Before the intervention, after the intervention. Method of measurement: asking people and determining the intensity according to the Visual Analogue Scale. Anemia rate based on KT/V calculation. Timepoint: Before the intervention, after the intervention. Method of measurement: It is calculated based on measuring the level of hemoglobin. Urea level. Timepoint: Before the intervention, after the intervention. Method of measurement: serum level per milliliter of blood recorded in the laboratory. Creatinine level. Timepoint: Before the intervention, after the intervention. Method of measurement: serum level per milliliter of blood recorded in the laboratory. Serum PTH level. Timepoint: Before the intervention, after the intervention. Method of measurement: serum level per milliliter of blood recorded in the laboratory. Muscle mass. Timepoint: Before the intervention, after the intervention. Method of measurement: It is calculated with a bio-impedance analyzer (BIA). Hemodialysis quality based on KT/V calculation. Timepoint: Before the intervention, after the intervention. Method of measurement: Dialysis quality is measured in this center or the KT/V index. (K= Clearance, T= Time on HD, V= Volume of distribution of Urea). Cholesterol, triglyceride, and HDL and LDL serum levels. Timepoint: Before the intervention, after the intervention. Method of measurement: serum level per milliliter of blood recorded in the laboratory. Serum ferritin level. Timepoint: Before the intervention, after the intervention. Method of measurement: serum level per milliliter of blood recorded in the laboratory. Serum albumin level. Timepoint: Before the intervention, after the intervention. Method of measurement: serum level per milliliter of blood recorded in the laboratory. Zahrawi Pharmaceutical Company Rasht University of Medical Sciences Zahrawi Pharmaceutical Company Approved 2022-08-31 Research Ethics Committee of Gilan University of Medical Sciences Rasht, Namjo St., Shahid Siyadati St. in front of 17 Shahrivar Hospital, University Research and Technology Vice-Chancellor Rasht Guilan Iran (Islamic Republic of)