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IRCT20190806044461N1 IRCT 2019-08-23 Zahedan University of Medical Sciences Effect of zinc sulfate in diabetic hemodialysis patients The effect of zinc sulfate on serum copeptin, C-Reactive protein, insulin resistance and nutritional status in diabetic hemodialysis patients 2019-08-23 anticipated 40 Complete https://irct.ir/trial/41403 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Diabetic hemodialysis patients with inclusion criteria enter as available. Then they will be divided into two groups(case and control) using the file number through random variable, Blinding description: Patients and nurses ward and statistics Adviser do not know about the drug and placebo. 3 Chronic kidney disease. Intervention 1: Intervention group: The zinc-supplementation group(n=20) will receive a 220-mg zinc sulfate capsule(containing 50 mg zinc) manufactured by Alhavi Pharmaceutical Company (Tehran, Iran); for 8 weeks. Intervention 2: Control group:The control-group(n=20) will receive a placebo capsule(220-mg corn starch), for 8 weeks. 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 I still don't have enough information about IPD publication
public Razieh Hosseini
No 9; Dr Shariati Ave.
Nour Abad Mammasani Iran (Islamic Republic of) 73517-38177 +98 71 4252 0479 razieh.hosseini7759@gmail.com Zahedan University of Medical Sciences scientific Razieh Hosseini
No 9; Dr Shariati Ave
Nour Abad Mammasani Iran (Islamic Republic of) 73517-38177 +98 71 4252 0479 razieh.hosseini7759@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Diabetic hemodialysis patients(Pass at least 6 months from hemodialysis); Age:15-70; Not having inflammatory diseases affecting on serum inflammatory markers; One month before the study began no supplements containing antioxidants,zinc supplement,vitamins E and C supplements; Steroid and non-steroidal anti-inflammatory drugs should not be used. 15 years 70 years Both If the patients have been taking antibiotics for the past month and with infectious or feverish disease. Also Diseases affecting serum copeptin like severe cardiovascular disease, Hypothyroidism ,hyperthyroidism and sepsis are not included in this study. N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Placebo Intervention group: The zinc-supplementation group(n=20) will receive a 220-mg zinc sulfate capsule(containing 50 mg zinc) manufactured by Alhavi Pharmaceutical Company (Tehran, Iran); for 8 weeks. Control group:The control-group(n=20) will receive a placebo capsule(220-mg corn starch), for 8 weeks. Serum copeptin. Timepoint: Before and after 8-week intervention. Method of measurement: It measured by ELISA method with standard kit. Serum insulin. Timepoint: Before and after 8-week intervention. Method of measurement: It measured by ELISA method with standard kit. C-Reactive-Protein. Timepoint: Before and after 8-week intervention. Method of measurement: It measured by ELISA method with standard kit. Nutritional status. Timepoint: Before and after 8-week intervention. Method of measurement: Food Frequency Questionnaire. Insulin resistance. Timepoint: Before and after 8-week intervention. Method of measurement: Homeostasis model assessment measuring insulin resistance. Zahedan University of Medical Sciences Approved 2019-07-21 Ethics committee of Zahedan University of medical sciences No. 9, Dr shariati Ave. Nour Abad Fars Iran (Islamic Republic of)