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IRCT20231119060103N1 IRCT 2023-11-24 Arak University of Medical Sciences Evaluation of the effect of vitamin E therapy on children with acute kidney injury Evaluation of the effect of vitamin E therapy on children with acute kidney injury 2023-11-12 anticipated 96 Complete https://irct.ir/trial/73866 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done, for this purpose, the participants will be assigned to two intervention and control groups according to the order of arrival and based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. . Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced. 3 Acute kidney injury. Intervention 1: intervention group In addition to the routine treatment with fluid therapy, patients are given vitamin E drops from the "Behsa" company, each milliliter of which contains 10 international units of vitamin E, for 10 day will receive. Age 1-3 years: 18 drops of the desired drug, which is equivalent to 0.9 ml. Age 4-8 years: 21 drops of the desired drug, which is equivalent to 1.05 ml. Age 9-13 years: 33 drops of the desired drug, which is equivalent to 1.65 It is milliliters. Intervention 2: Control group: The control group will receive only routine treatment which includes fluid therapy. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions, as well as people working in the industry, can apply for them Conditions: There are no other conditions Where to obtain: To the main person responsible for the study; Dr. Ali Arjmand can be contacted at Aliarjmand1@yahoo.com How to obtain: The applicant can contact the person in charge of the study through the email address and get access to the information as soon as possible after the request Comments:
public Dr. Ali Arjmand
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
Arak Iran (Islamic Republic of) 3819693181 +98 86 3313 4715 Aliarjmand1@yahoo.com Arak University of Medical Sciences scientific Dr. Ali Arjmand
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
Arak Iran (Islamic Republic of) 3819693181 +98 86 3313 4715 Aliarjmand1@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) 1. People with acute kidney injury between the ages of 1 and 13 admitted to Amirkabir Hospital 2. Have the necessary cooperation in following up the treatment 3. Completing the informed consent form. 1 year 13 years Both People who do not want to participate in the study N17.9 Acute kidney failure, unspecified Treatment - Drugs Treatment - Drugs intervention group In addition to the routine treatment with fluid therapy, patients are given vitamin E drops from the "Behsa" company, each milliliter of which contains 10 international units of vitamin E, for 10 day will receive. Age 1-3 years: 18 drops of the desired drug, which is equivalent to 0.9 ml. Age 4-8 years: 21 drops of the desired drug, which is equivalent to 1.05 ml. Age 9-13 years: 33 drops of the desired drug, which is equivalent to 1.65 It is milliliters Control group: The control group will receive only routine treatment which includes fluid therapy The assessment of acute kidney injury is done by measuring the serum creatinine level. Timepoint: Measurement of serum creatinine level at the beginning of the study, 48 hours later and at the time of discharge. Method of measurement: blood sample. Arak University of Medical Sciences Approved 2023-09-30 Ethics committee of Arak University of Medical Sciences Sardasht St., Salamat St., Arak Medical Sciences Dormitory Arak Markazi Iran (Islamic Republic of) Approved 2023-11-12 Ethics committee of Arak University of Medical Sciences Sardasht St., Salamat St., Arak Medical Sciences Dormitory Arak Markazi Iran (Islamic Republic of)