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IRCT20100102002954N15 IRCT 2019-04-25 Vice chancellor for research; Shahroud University medical and Sciences Evaluation effects of Vitamin C and Ferrous Sulfate in Restless leg treatment of hemodialysis patients Comparing the effects of Vitamin C and Ferrous Sulfate with Ferrous Sulfate along on Restless leg of hemodialysis patients, a double blind randomized control trial 2019-04-21 anticipated 80 Complete https://irct.ir/trial/2841 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients entered into the study are divided into two groups of intervention and control. Patients in the intervention group; in addition to get the iron pill, will also receive vitamin C tablets. Patients in the control group will be only receive iron tablets, Randomization description: Randomization method: use block. Random unit: individual. Randomization tool: statistical software. Sequence building: using randomized 4 in 4 blocks. Hiding method: use envelopes in the package, Blinding description: In this study, patients; clinical caregiver and analyzer it are blinded. The division of patients into two groups A and B is done by a qualified nurse who has no knowledge of the actions performed in the two groups. Do clinical examination of patients and results recorder will be done by a qualified nurse without any knowledge of the type of intervention and patients. 2-3 Restless legs syndrome. Intervention 1: In the intervention group; treatment with vitamin C tablets plus ferrous sulfate tablets with initial dose of vitamin C (250 mg) plus a ferrous sulfate (60 mg) daily in the first month; two tablets of vitamin C (500 mg) plus two Ferrous sulfate tablets (120 mg) in the second month and 3 tablets of vitamin C (750 mg) plus three tablets of Ferrous sulfate (180 mg) in the third month will be prescribed. Intervention 2: Control group: In the control group; treatment will be done only one Ferrous sulfate tablet (60 mg) in the first month; two tablets of Ferrous sulfate (120 mg) in the second month and three tablets of Ferrous sulfate (180 mg) in the third month. 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.Mohammad Bagher Sohrabi
Imam Hossein Hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 mb.sohrabi@shmu.ac.ir Shahroud University of Medical Sciences scientific Dr.Monireh Amerian
Imam Hossein hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 amerian1060@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Patients under regular hemodialysis Age over 15 and under 70 years of patients Definitive diagnosis of restless leg syndrome No specific medication associated with restless leg therapy in the last two weeks The absence of underlying disorders of the skeletal system Having of satisfaction in research 15 years 70 years Both Need to kidney transplant before study completion Hyperparathyroidism The presence of any underlying abnormalities of the skeletal system Unstable of vital signs and hemodynamic Dissatisfaction in research G25.8 Other specified extrapyramidal and movement disorders Treatment - Drugs Treatment - Drugs In the intervention group; treatment with vitamin C tablets plus ferrous sulfate tablets with initial dose of vitamin C (250 mg) plus a ferrous sulfate (60 mg) daily in the first month; two tablets of vitamin C (500 mg) plus two Ferrous sulfate tablets (120 mg) in the second month and 3 tablets of vitamin C (750 mg) plus three tablets of Ferrous sulfate (180 mg) in the third month will be prescribed. Control group: In the control group; treatment will be done only one Ferrous sulfate tablet (60 mg) in the first month; two tablets of Ferrous sulfate (120 mg) in the second month and three tablets of Ferrous sulfate (180 mg) in the third month. Severity of Restless Leg Syndroum. Timepoint: Once a Month. Method of measurement: Standard Questioner of Restless Leg syndrome evaluation. Vice chancellor for research; Shahroud University medical and Sciences Approved 2019-03-11 Shahroud University of Medical Sciences Shahroud University of Medical Sciences; 7 Tir squer, Shahroud Shahroud Semnan Iran (Islamic Republic of)