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IRCT20191223045862N1 IRCT 2020-03-14 Oroumia University of Medical Sciences The effect of oral supplementation of zinc on glycemic status, lipid profile and body composition in non-diabetic hemodialysis patients The effect of oral supplementation of zinc on glycemic status, lipid profile and body composition in non-diabetic hemodialysis patients 2019-06-07 anticipated 66 Complete https://irct.ir/trial/44708 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: At the end of the sampling, individuals were contacted to begin the intervention.At the beginning of the intervention, the patients were assigned in groups 1 and 2 respectively. The first person in group 1, the second person in group 2 continued to 66, Blinding description: Individuals were coded into groups 1 and 2. Also Cans containing Zinc gluconate and placebo tablets were coded 2 and 1 by someone other than the researcher and provided to the researcher in order to ensure that the researcher was not informed about the type of tablet consumed by each group. 3 non-diabetic hemodialysis patients. Intervention 1: Intervention group: Daily consumption of a 30 mg tablet of zinc gluconate for 60 days, manufactured by Dineh Iranian Pharmaceutical Company with standard therapy. Intervention 2: Control group: Daily consumption of a placebo tablet containing corn starch, made by Dineh Iranian Pharmaceutical Company with standard treatment. Yes - There is a plan to make this available What will be shared: The data file is accessible after the results are published. When: Start of access period 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: Before starting the analysis, the results should be coordinated with the researcher for guidance. Where to obtain: Call the following number if needed. 09145268940 How to obtain: No special process is required. Comments:
public Mohammad Mohajjel Halim
Shohada dormitory, Naslow Road.,Oroumia Town
Oroumia Iran (Islamic Republic of) 5331678577 +98 41 3344 5257 mohammad.mohajjel.h@gmail.com Oroumia University of Medical Sciences scientific Mohammad Mohajjel Halim
Shohada dormitory, Naslow Road., Oroumia Town
Oroumia Iran (Islamic Republic of) 5331678577 +98 41 3344 5257 mohammad.mohajjel.h@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) At least 6 months have passed since the start of hemodialysis. Patients undergo hemodialysis 3 times a week for 4-3 hours. Non-diabetic hemodialysis patients 18 years no limit Both Patients are candidates for kidney transplant. Patients with any symptoms of gastrointestinal disorders. Patients taking penicillamine medication. Patients taking glucocorticoid medication. Patients taking estrogen medication. Patients taking the antibiotic medication. Women taking oral contraceptives. Patients taking lipid lowering medications. Patients with zinc malabsorption (Acroderma enteropathica). Pregnant and lactating women. N18.5 Chronic kidney disease, stage 5 Prevention Placebo Intervention group: Daily consumption of a 30 mg tablet of zinc gluconate for 60 days, manufactured by Dineh Iranian Pharmaceutical Company with standard therapy Control group: Daily consumption of a placebo tablet containing corn starch, made by Dineh Iranian Pharmaceutical Company with standard treatment Serum zinc level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum zinc level was measured using Dialab kit by BT-1500 autoanalyzer in micrograms / dL. Insulin resistance. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Insulin resistance was calculated using the homeostasis model formula (HOMA-IR) as follows. HOMA-IR = [fasting insulin (μU/L) × fasting blood glucose (mg/dl)]/405. Serum albumin level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum albumin levels were measured using Dialab kit by BT-1500 autoanalyzer and in g / dl. Serum insulin level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum insulin level were measured using Dialab ELISA kit. Serum glucose level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Glucose level was measured using Pars Co kit and glucose oxidase enzymatic assay. Total cholesterol concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Total cholesterol concentration was measured using Dialab kit by enzymatic photometry. LDL-cholesterol concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Dialab kit was used to measure serum LDL-cholesterol concentration. HDL-cholesterol concentration. Timepoint: Dialab kit was used to measure serum HDL-cholesterol concentration. Method of measurement: At the beginning (day 0) and end of the intervention (day 60). Serum triglyceride concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum triglyceride concentration was measured using Dialab kit and enzymatically. Body composition. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: BIA model InBody 770 was used to determine body composition indices. Oroumia University of Medical Sciences Approved 2018-10-03 Ethics committee of Oroumia University of Medical Sciences Oroumia University of medical science, Resalat Blvd.,Oroumia Town Oroumia West Azarbaijan Iran (Islamic Republic of)