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IRCT20230622058559N1 IRCT 2023-08-15 Shahid Beheshti University of Medical Sciences The Effect of Oral Nutritional protein Supplement on Nutritional Status and protein energy wasting of Hemodialysis Patients The Effect of Oral Nutritional protein Supplement on Nutritional Status and protein energy wasting of Hemodialysis Patients : a randomized double-blind, placebo-controlled trial 2023-08-06 anticipated 52 Complete https://irct.ir/trial/71335 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible people will be randomly assigned to one of the two groups to receive medicine or placebo with a ratio of 1:1. The randomization method will be permuted block randomization, and the blocks will be based on the sample size in sizes 2, 4, 6, 8, 10 or more using the "Ralloc" package in STATA software. Patients will be included in each group based on the determined sample size and based on the list of randomized individuals (along with a specific research code for each individual), Blinding description: This study is double-blind. The medicine and placebo needed for the people participating in the study will be sent to the treatment center from the manufacturing company in a completely covered and indistinguishable form for use by patients. The people participating in the study and the clinical evaluators of the patients (specialist doctors) will not be aware of the drug or placebo. 3 Chronic kidney failure stage 5. Intervention 1: Consumption of VM-protein powder in the amount of 24 grams orally manufactured by Iran Daru Company for 6 months on a daily basis (within 6 months from the start of the study). Intervention 2: Control group: Taking 24 grams of placebo powder orally manufactured by Iran Daru Company for 6 months on a daily basis (within 6 months of the start of the study). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic institutions Conditions: Statistical analyzes are performed on the delivered data Where to obtain: Dialysis Department of Imam Hossein Hospital How to obtain: After a period of 6 months Comments:
public Farnaz Saberian
Shahid Madani Street, Imam Hossein Hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 farnaz.saberian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Farnaz Saberian
Shahid Madani Street, Imam Hossein Hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 farnaz.saberian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 20-70 years albumin<4gr/dl the patient under hemodialysis from 6 months ago (at least 2 times in a week) malnutrition based on must score>1 18 years no limit Both lack of informed consent for participating history of chronic diseases such as liver diseases, malignancies, severe cardiopulmonary diseases history of any surgery within past 3 months history of hospitalization due to malignancies within past 3 months history of allergy due to oral nutritional supplements N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Placebo Consumption of VM-protein powder in the amount of 24 grams orally manufactured by Iran Daru Company for 6 months on a daily basis (within 6 months from the start of the study) Control group: Taking 24 grams of placebo powder orally manufactured by Iran Daru Company for 6 months on a daily basis (within 6 months of the start of the study) Bio-impedance device analysis. Timepoint: At the beginning of the study (before the start of the intervention) and 6 months after the start of VM protein. Method of measurement: Bio-impedance device. MUST score. Timepoint: before the start of the intervention and six months after the start of vm protein. Method of measurement: Malnutrition Universal Screening Tool (MUST). Shahid Beheshti University of Medical Sciences Approved 2023-06-03 Ethics Committee of Shahid Beheshti University of Medical Sciences 439 Heydari St., Unit 13, South Majidiyeh tehran Tehran Iran (Islamic Republic of)