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IRCT20200827048539N1 IRCT 2020-10-19 Esfahan University of Medical Sciences The Effect of Zinc on Hemoglobin in Hemodialysis Patients Evaluation of the Effect of Zinc Prescription on Hemoglobin Level and Erythropoetin Dose Requirement in Hemodialysis Patients in comparison with Placebo 2020-10-22 anticipated 30 Complete https://irct.ir/trial/50649 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation in current study will be done using permuted block randomization of block size 4, and each patient is as a unit of randomization, and random sequence generation will be done using statistical software and will be conducted using sealed envelops, Blinding description: All the patients, investigators, health care workers and drug prescribers will be blinded. Drug and placebo will be prepared in simple and similar boxes by a trained person who is not in the study, does not work in the dialysis ward and does not have any relations with any of the people in the study group or health care workers. Drug and placebo are marked by labels A and B in similar boxes. Then they are shared by health care workers who have no contact with the divider of the drug. This drug A and B are randomly distributed among patients who have been sampled randomly. The test results and other data are gathered by the investigators. Only data analyzer is informed about drug A and B. 3 Condition 1: End stage renal disease on hemodialysis. Condition 2: Anemia. Intervention 1: Intervention group: 30 hemodialysis patients enroll in the study using 30 mg zinc gluconate tablets containing 30 mg elemental zinc (Dineh pharmaceutical Co., Tehran, Iran). The patients are taught to take one tablet with water after breakfast; and on dialysis days, after the meal post dialysis session; daily for 6 months. The drug will be offered in hemodialysis ward weekly and to make sure the drug is taken by the patients, they are asked to return the empty box. Intervention 2: Control group: 30 hemodialysis patients enroll in the study and will receive the placebo with the same size, smell, color and packaging produced by Isfahan Faculty of Pharmacy. The patients are taught to take the placebo with water daily after breakfast, and on dialysis days after the meal post dialysis session; for 6 months. The patients will receive the placebo in hemodialysis wards weekly and to make sure the drug is taken by the patients, they are asked to return the empty box. Yes - There is a plan to make this available What will be shared: 1- Primary outcome including hemoglobin level in two groups of intervention 2- Secondary outcome including erythropoetin dose changes in two groups of intervention When: Starting 6 months after publication To whom: Academic persons only can apply to receive it. Conditions: 1- Compare with or add to similar data of other studies 2- Doing statistical analysis other than we did provided that the right of first investigators be preserved. Where to obtain: By e-mail: seirafian@med.mui.ac.ir How to obtain: One month after receiving inquiry, email and mobile number, it will be responsed. Comments:
public Shiva Seirafian
Isfahan Kidney Diseases Research Center, Al-Zahra Hospital, Soffeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 2664 seirafian@med.mui.ac.ir Esfahan University of Medical Sciences scientific Shiva Seirafian
Isfahan Kidney Diseases Research Center, Al-Zahra Hospital, Soffeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 2664 seirafian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who have been on hemodialysis for at least 3 months More than 18 years of age Consensus on participation in the study Hemoglobin level less than 12 g/dl Patients who are under ongoing therapy with injected erythropoetin Not taking cholrthalidone, tetracycline and penicillin Non pregnant and breastfeeding On hemodialysis for at least twice a week Not having cancer, acute inflammatory disease and severe hepatic failure 18 years no limit Both Patients wanting to discontinue the cooperation for any reason Discontinuing hemodialysis therapy Surgical operation during the study Blood transfusion during the study Hemorrhage during the study Development of malignant tumors during the study Pregnancy during the study Intolerance of drug Non-compliance with the intervention (less than 70%) Z99.2 N18.6 Dependence on renal dialysis End stage renal disease Treatment - Drugs Treatment - Drugs Intervention group: 30 hemodialysis patients enroll in the study using 30 mg zinc gluconate tablets containing 30 mg elemental zinc (Dineh pharmaceutical Co., Tehran, Iran). The patients are taught to take one tablet with water after breakfast; and on dialysis days, after the meal post dialysis session; daily for 6 months. The drug will be offered in hemodialysis ward weekly and to make sure the drug is taken by the patients, they are asked to return the empty box. Control group: 30 hemodialysis patients enroll in the study and will receive the placebo with the same size, smell, color and packaging produced by Isfahan Faculty of Pharmacy. The patients are taught to take the placebo with water daily after breakfast, and on dialysis days after the meal post dialysis session; for 6 months. The patients will receive the placebo in hemodialysis wards weekly and to make sure the drug is taken by the patients, they are asked to return the empty box. Blood hemoglobin level. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Hemoglobin measurement by automated hematology analyzer, sysmex-21N, Japan. The amount of prescribed erythropoetin. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: By observation and questionnaire. Serum zinc level. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Laboratory AUDIT kit (Delta Darman Part, Tehran, Iran), measured by OLYMPUS 2700 autoanalyzer, Japan. Esfahan University of Medical Sciences Approved 2020-08-25 Ethics committee of Isfahan University of Medical Sciences Vice-Chancellery for Research and Technology, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan Isfehan Iran (Islamic Republic of)