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IRCT20221111056466N1 IRCT 2022-12-19 Arak University of Medical Sciences "Effect of vitamin E in preventing kidney problems in thalassemia patients" Evaluation of the effect of vitamin E on prevention of acute kidney injuray and Fanconi syndrome caused by iron chelators in thalassemia patients 2022-12-22 anticipated 50 Complete https://irct.ir/trial/66866 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In the intervention group, people receive vitamin E daily for one month, and in the control group, they receive the standard treatment before entering the study, Randomization description: Randomization method: simple randomization Each patient in the desired community has an equal chance of being selected Randomization Unit: Individual Randomization tools: Excel Microsoft. 3 Condition 1: Thalassemia. Condition 2: Acute Kidney Injury. Condition 3: Fanconi syndrome. Condition 4: Abnormal Kidney function. Intervention 1: Intervention group: In addition to the standard treatment, this group receives a daily iron chelator called Jedneo 360 mg tablet with the generic name Defrasirox of Swiss company NOVARTIS, and vitamin E with a dose of 400 mg of E-Vigel 400mg Softgel of Iran's Dana Pharmaceutical Company. Deferasirox It leads to an increase in the excretion of iron through feces. Deferasirox is prescribed in cases where the amount of iron in the body is chronically accumulated due to blood transfusion or diseases such as thalassemia to eliminate excess iron. Intervention 2: Control group: This standard treatment group receives a daily intake of an iron chelator called Jadenio 360 mg tablet with the generic name Deferasirox by Novartis Switzerland. Deferasirox leads to an increase in the excretion of iron through feces. Deferasirox is prescribed in cases where the amount of iron in the body is chronically accumulated due to blood transfusions or diseases such as thalassemia to eliminate excess iron. Yes - There is a plan to make this available What will be shared: All tests taken including cr, gfr, p, fbs, bun/cr, vbg, u/a When: Access starts 6 months after the results are published To whom: For all people related to medicine, pharmacy, and laboratory sciences Conditions: no limitation Where to obtain: Mahdic moradigoudarzi moradi_goudarzi@yahoo.com How to obtain: Please, after introducing yourself and the field you are working in, ask for the documentation of this project so that it will be sent to him/her a week later. Comments:
public Mahdi Moradigoudarzi
No 12, Namavaran 9 Alley, Sepehr St, Andisheh Quarter
Arak Iran (Islamic Republic of) 6919714946 +98 66 4230 8306 moradi_goudarzi@yahoo.com Arak University of Medical Sciences scientific Mahdi Moradigoudarzi
No 12, Namavaran 9 Alley, Sepehr St, Andisheh Quarter
Arak Iran (Islamic Republic of) 6919714946 +98 66 4230 8306 moradi_goudarzi@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients with thalassemia are covered by Amir Kabir Arak Hospital no limit no limit Both All patients who are covered by Amirkabir Hospital but do not consent to participate in the study. D56.1 N17.0 E72.0 R94.4 Beta thalassemia Acute kidney failure with tubular necrosis Disorders of amino-acid transport Abnormal results of kidney function studies Treatment - Drugs Treatment - Drugs Intervention group: In addition to the standard treatment, this group receives a daily iron chelator called Jedneo 360 mg tablet with the generic name Defrasirox of Swiss company NOVARTIS, and vitamin E with a dose of 400 mg of E-Vigel 400mg Softgel of Iran's Dana Pharmaceutical Company. Deferasirox It leads to an increase in the excretion of iron through feces. Deferasirox is prescribed in cases where the amount of iron in the body is chronically accumulated due to blood transfusion or diseases such as thalassemia to eliminate excess iron. Control group: This standard treatment group receives a daily intake of an iron chelator called Jadenio 360 mg tablet with the generic name Deferasirox by Novartis Switzerland. Deferasirox leads to an increase in the excretion of iron through feces. Deferasirox is prescribed in cases where the amount of iron in the body is chronically accumulated due to blood transfusions or diseases such as thalassemia to eliminate excess iron. Creatinine level. Timepoint: It will be checked on the first day of the study and 48 hours and 7 days after the start of the study. Method of measurement: blood samples. Glomerular filtration rate. Timepoint: It will be checked on the first day of the study and 48 hours and 7 days after the start of the study. Method of measurement: blood sample. Blood phosphorus level. Timepoint: It is checked on the first day of the study and 30 days after the start of the study. Method of measurement: blood sample. Urine glucose level. Timepoint: It is checked on the first day of the study and 30 days after the start of the study. Method of measurement: urine sample. Venous blood gas level. Timepoint: It is checked on the first day of the study and 30 days after the start of the study. Method of measurement: blood sample. The ratio of blood urea nitrogen to creatinine. Timepoint: It is checked on the first day of the study and 30 days after the start of the study. Method of measurement: blood sample. Arak University of Medical Sciences Approved 2022-07-31 Ethics Committee of Arak University of Medical Sciences Alam-ol-Hoda st, Shahid Shiridi st arak Markazi Iran (Islamic Republic of)