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IRCT20210301050546N1 IRCT 2025-08-02 Shahid Beheshti University of Medical Sciences Investigating the effect of protein nutritional supplements on erythropoietin resistance in individuals with protein-energy wasting syndrome undergoing hemodialysis Investigating the effect of protein nutritional supplements on erythropoietin resistance in individuals with protein-energy wasting syndrome undergoing hemodialysis at Imam Hussein Hospital: A randomized clinical trial 2025-08-06 anticipated 50 Complete https://irct.ir/trial/84944 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible subjects will be randomly assigned to one of two groups, either the supplement or the control, in a 1:1 ratio. The randomization method will be permuted block randomization, with blocks based on sample size in 7 blocks of sizes 4, 6, 8, and 10 using the “Ralloc” package in STATA software. Participants will be assigned to each group based on the sample size determined and the list of randomized individuals (along with a specific research code for each individual). N/A Patients with protein energy wasting syndrome undergoing hemodialysis. Intervention 1: Intervention group: 25 patients, as prescribed and under the supervision of a nutritionist and nephrologist, use VM protein powder for three months. VM-protein 24 grams orally, manufactured by Iran Darou Company, daily for three months. Intervention 2: Control group: Adherence to the standard treatment protocol for hemodialysis patients without making any changes to their lifestyle. 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 Since I haven't started studying yet, I haven't decided on this issue yet.
public Ghazale Ghorbani Garakani
No. 6. Seyed Khandan, Abuzar Ghaffari South, 6th Alley, , Unit 1
Tehran Iran (Islamic Republic of) 1661645513 +98 21 2286 3637 ghazaal.ghorbani.1@gmail.com Shahid Beheshti University of Medical Sciences scientific Ghazale Ghorbani Garakani
No. 6. Seyed Khandan, Abuzar Ghaffari South, 6th Alley, , Unit 1
Tehran Iran (Islamic Republic of) 1661645513 +98 21 2286 3637 ghazaal.ghorbani.1@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with chronic kidney disease (CKD) who are undergoing chronic hemodialysis for at least 6 months. Diagnosis of protein-energy wasting syndrome based on international criteria Weight loss ≥ 5% in the last 3 months or body mass index less than 23 Decreased muscle mass based on BIA measurement or SGA index Decreased serum albumin (<3.8 g/dL) or decreased serum TIBC level (<200 mg/dL) Reduced energy and protein intake (<25 kcal/kg/day and <1.0 g/kg/day) Receiving erythropoietin treatment for at least the last 3 months Written consent to participate in the study no limit no limit Both Acute inflammatory diseases or active infections Malignant diseases (active cancer) or receiving chemotherapy Anemia due to non-renal causes (MDS hemoglobinopathy) Taking steroids or immunosuppressant drugs N18.9 Chronic kidney disease, unspecified Treatment - Other Treatment - Other Intervention group: 25 patients, as prescribed and under the supervision of a nutritionist and nephrologist, use VM protein powder for three months. VM-protein 24 grams orally, manufactured by Iran Darou Company, daily for three months. Control group: Adherence to the standard treatment protocol for hemodialysis patients without making any changes to their lifestyle Serum erythropoietin changes. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination. Erythropoietin resistance index. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination. Serum hemoglobin level. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination. Changes in serum albumin and TIBC levels. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination. Changes in serum ferritin levels. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination. CRP and ESR changes. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination. Changes in body analysis indicators. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: InBody S10 device. Shahid Beheshti University of Medical Sciences Approved 2025-07-12 Ethics Committee of Shahid Beheshti University of Medical Sciences No. 6. Seyed Khandan, Abuzar Ghaffari South, 6th Alley, , Unit 1 Tehran Tehran Iran (Islamic Republic of)