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IRCT20150706023084N10 IRCT 2021-10-09 Islamic Azad University Trial of vitamin E on pruritus, appetite and muscle cramps in hemodialysis patients The effect of vitamin E on muscle cramps, appetite and pruritus in hemodialysis patients in dialysis wards of hospitals affiliated to Islamic Azad University of Tehran 2021-10-10 anticipated 40 Complete https://irct.ir/trial/58784 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sample selection and allocation in this study was done randomly with the help of rand function of Excel software. With the help of this software, the sequence of drug and placebo distribution was determined between the two groups of patients and with the help of someone outside the study, the groups receiving the drug and placebo were divided according to the mentioned sequence and the desired compounds were delivered to the patients.This information will be recorded and maintained by the said person until the end of the research, Blinding description: In this study, the physician, researcher, data analyst, and patient taking the drug are unaware of the type of combination they will be taking (drug or placebo) and do not understand what combination they are receiving. The recipients of the drug and placebo were divided and the desired compounds were delivered to the patients and this information will be recorded and kept by the said person until the end of the research. 3 Hemodialysis patients. Intervention 1: Intervention group: 20 hemodialysis patients who will receive 400 units of vitamin E daily after lunch for 12 weeks. Intervention 2: Control group: 20 hemodialysis patients who will receive placebo of vitamin E contains oral paraffin daily after lunch for 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 Due to the multi-blind nature of the study and the fact that only one outsider is aware of the combination of case and control groups, this file has not been published and only the final data will be published.
public Maryam Shiehmorteza
No.99, Yakhchal street, Dr. Shariati Avenue
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 shiehmorteza@iaups.ac.ir Islamic Azad University scientific Maryam Shiehmorteza
No.99, Yakhchal street, Dr. Shariati Avenue
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 shiehmorteza@iaups.ac.ir Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Chronic kidney disease in the end stages Hemodialysis patients Age range 18 to 90 years old Signature informed consent form Start dialysis at least three months ago 18 years 90 years Both History of thyroid disease Use of vitamin E Pregnancy Allergy to vitamin E or placebo History of chronic gastrointestinal disease History of chronic dermatologic disease History of liver disease such as cholestasis N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Placebo Intervention group: 20 hemodialysis patients who will receive 400 units of vitamin E daily after lunch for 12 weeks Control group: 20 hemodialysis patients who will receive placebo of vitamin E contains oral paraffin daily after lunch for 12 weeks Muscle cramp score. Timepoint: The time periods of muscle cramp severity were measured at the beginning of the study (before the intervention) and 12 weeks after the start of vitamin E use. Method of measurement: In the study "the effect of vitamin E supplement on muscle cramps and itching and appetite in hemodialysis patients" how to measure muscle cramps is a questionnaire of professors of Tarbiat Modares University in relation to the evaluation of muscle cramps. Itching score. Timepoint: The time periods of itching severity were measured at the beginning of the study (before the intervention) and 12 weeks after the start of vitamin E use. Method of measurement: In the study "The effect of vitamin E supplementation on muscle cramps and itching and appetite in hemodialysis patients" is yusovich questionnaire on how to measure itching. Appetite score. Timepoint: The appetite changes were measured at the beginning of the study (before the intervention) and 12 weeks after the start of vitamin E use. Method of measurement: In the study "The effect of vitamin E supplementation on muscle cramps and itching and appetite in hemodialysis patients" is Bacter and Doyer questionnaire on how to measure appetite . Islamic Azad University Approved 2021-09-13 Ethics committee of Department of Pharmaceutical Sciences, Tehran Islamic Azad University of Medical No.99, Yakhchal street, Dr.Shariati Avenue Tehran Tehran Iran (Islamic Republic of)