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IRCT20100102002954N25 IRCT 2022-01-31 Shahroud University of Medical Sciences Evaluation of the effect of vitamin C on some blood indicators of dialysis patients Evaluation of the effect of vitamin C supplementation on selected blood laboratory indicators of chronic kidney diseases, a double blind randomized control trial 2022-02-20 anticipated 106 Complete https://irct.ir/trial/61569 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were allocated to intervention and control groups according to random allocation table that illustrated by a statistician. Randomization was done using permuted block randomization method (Block size was 4) using blocked random allocation syntax in SPSS software. For calculation sample size was 106 and number of blocks was 27. Allocation concealment was done using closed opaque envelope, Blinding description: In this study, patients; clinical caregiver, outcome evaluator and analyzer it are blinded. The division of patients into two groups intervention and control, review and record test results is done by a qualified nurse who has no knowledge of the actions performed in the two groups. Data analysis will also be performed by a project epidemiologist who has no knowledge of patient grouping. 2-3 Chronic kidney disease. Intervention 1: Intervention group: for patients in the intervention group, after justifying the patients and providing the necessary training, routine treatment (including: hemodialysis, medication and diet) + 250 mg of vitamin C tablets once a day during the study (12 weeks) is prescribed. Intervention 2: Control group: for patients in the control group, after justifying the patients and providing the necessary training, only routine treatment (including: hemodialysis, medication and diet) is prescribed during the study (12 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 After completing the research and summarizing the results, it will be decided.
public Dr. Mehdi Feyzabadi
Imam Hossein hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 mehdifyzabadi082@gmail.com Shahroud University of Medical Sciences scientific Dr. Hoofar Rafiei
آدرس خیابان Imam Hossein hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 rafiei@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Patients with definitive diagnosis of chronic kidney disease and need dialysis; Age range 15-65 years; History of dialysis for at least six consecutive months; Stable vital signs; Have a controlled and consistent diet throughout the study; Conscious consent to participate in research. 15 years 65 years Both Existence of digestive problems such as severe nausea and vomiting; Existence of severe and relatively severe coagulation problems; Existence of chronic heart and liver disease at the same time; Take any vitamin C supplements in the past month; Any changes in diet without notice during the study; Withdrawal or regret of conducting research at any stage of research. N18.4 Chronic kidney disease, stage 4 (severe) Treatment - Drugs Treatment - Drugs Intervention group: for patients in the intervention group, after justifying the patients and providing the necessary training, routine treatment (including: hemodialysis, medication and diet) + 250 mg of vitamin C tablets once a day during the study (12 weeks) is prescribed. Control group: for patients in the control group, after justifying the patients and providing the necessary training, only routine treatment (including: hemodialysis, medication and diet) is prescribed during the study (12 weeks). Measurement of serum potassium. Timepoint: Once a month. Method of measurement: Standard laboratory method. Measurement of serum calcium. Timepoint: Once a month. Method of measurement: Standard laboratory method. Blood sugar measurement. Timepoint: Once a month. Method of measurement: Standard laboratory method. Measurement of hemoglobin. Timepoint: Once a month. Method of measurement: Standard laboratory method. Dialysis adequacy measurement. Timepoint: Once a month. Method of measurement: Dialysis adequacy indicators KT/V. Vice chancellor for research; Shahroud University medical and Sciences Approved 2022-01-05 Shahroud University of Medical Sciences Shahroud University of Medical Sciences; 7 Tir squer, Shahroud Shahroud Semnan Iran (Islamic Republic of)