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IRCT20210715051904N1 IRCT 2022-02-19 Boushehr University of Medical Sciences The effect of combination therapy of L-glutamine and hydroxyurea in patients with sickle cell anemia GLOBE Trial Efficacy of combination therapy of L-glutamine and Hydroxyurea in comparison with Hydroxyurea alone in patients with sickle cell anemia: a randomized, double-blinded clinical trial 2022-02-14 anticipated 126 Complete https://irct.ir/trial/57556 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized controlled clinical trial in which all patients are examined in two groups, which we represent with two symbols A and B. Group A will receive L-glutamine and hydroxyurea combination therapy in the intervention (intervention group) and group B will receive hydroxyurea treatment alone (control group). Participants in the study will be randomly divided into two groups A and B equal to .... individual. In order to randomly assign individuals to two equal groups to receive the intervention, the Permuted Block Randomization method with a block size of 6 has been used. The block randomization scheme was created using the free Randomization.com website (http://randomization.com). From the order of the Permuted Block Randomization table, the allocator and evaluator should not be aware of the type of intervention being performed on the individual and the size of the block. Thus, it can be said that the data allocation will remain hidden until the end of the study. Thus, each participant will be assigned to intervention or control groups and will enter the study. 1. A_______________________________________ 2. A___________________________________ 3. B___________________________________ 4. B___________________________________ 5. B___________________________________ 6. 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A_____________________________________ 121. A_____________________________________ 122. B_____________________________________ 123. B_____________________________________ 124. A_____________________________________ 125. B_____________________________________ 126. A_____________________________________, Blinding description: From the order of the Permuted Block Randomizotion table, the allocator and evaluator should not be aware of the type of intervention being performed on the individual and the size of the block. Thus, it can be said that the data allocation will remain hidden until the end of the study. In this way, each participant will be assigned to intervention or control groups and will be included in the study. Pain Crisis Judgment and Laboratory Tests: All pain crises reported in the case report forms will be recorded by the researchers. An independent judging panel consisting of two hematologists-oncologists who are unaware of the assignment of the trial team will evaluate each episode to determine whether the event meets the definition of a pain crisis for performance evaluation. 3 Sickle cell anemia, L-glutamine, hydroxyurea, pain crisis. Intervention 1: Intervention group: Intervention group: The allocation of two randomized block blinds is encoded in numbered envelopes and is prepared according to the number of samples and will be provided to the patient's attending physician. Therefore, eligible patients will be randomly divided into a 1: 1 ratio for L-glutamine and hydroxyurea combination therapy or hydroxyurea alone, with randomized block allocation. The planned treatment period will be 6 months, during which patients, in addition to consuming hydroxyurea, take L-glutamine powder orally twice a day at a dose of approximately 0.3 g / kg body weight per dose (10 g, 20 g). Grams or 30 grams [maximum dose] per day). The contents of the package will be mixed with an unheated drink or food and consumed immediately. Patients will be contacted by telephone each week between monthly visits to encourage adherence. The validity of the test group assignment and the correct supply of L-glutamine or placebo for each patient will be verified by an independent research drug service. Patients can receive blood transfusions and other necessary clinical treatments if needed. Intervention 2: Control group: The allocation of two randomized block blinds is encoded in numbered envelopes and is prepared according to the number of samples and will be provided to the patient's attending physician. Therefore, eligible patients will be randomly divided into a 1: 1 ratio for L-glutamine and hydroxyurea combination therapy or hydroxyurea alone, with randomized block allocation. The planned treatment period will be 6 months, during which the control group will receive placebo powder (100% maltodextrin) orally twice a day. Experimental drug and placebo in individual packages and visually identical contain 5 grams of white powder without taste is provided, and all packages will be returned by patients to assess compliance. The contents of the package will be mixed with an unheated drink or food and consumed immediately. Patients will be contacted by telephone each week between monthly visits to encourage adherence. The validity of the test group assignment and the correct supply of L-glutamine or placebo for each patient will be verified by an independent research drug service. Patients can receive blood transfusions and other necessary clinical treatments if needed. 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 There is no further information
public Nader Shakibazad
Tabib Medical Building (9th floor), Keshtirani crossroads, Boushehr, Iran
Boushehr Iran (Islamic Republic of) 7514799621 +98 77 3335 1048 shakibn@bpums.ac.ir Boushehr University of Medical Sciences scientific Nader Shakibazad
Tabib medical building (9th floor), Keshtirani crossroads, boushehr, Iran
Boushehr Iran (Islamic Republic of) 7514799621 +98 77 3335 1048 shakibn@bpums.ac.ir Boushehr University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with sickle-cell syndrome Age more than five-year-old No other accompanying hematologic diseases All patients should be on Hydroxyurea At least two (extreme) pain crises have been documented in the past year (defining a pain crisis as pain that results from treatment with a drug or injectable ketorolac in the emergency department (ED) (or outpatient treatment center) or during hospitalization. Becomes) 5 years no limit Both Occurrence of life-threatening events not related to SCD during treatment Patient dissatisfaction with participation in the study Serum albumin levels are less than 3 g / dL Internationally normalized ratios of prothrombin time are higher than 2.0 The treated with L-glutamine within 30 days prior to screening. D57 Sickle-cell disorders, Sickle-cell anaemia with crisis, Sickle-cell anaemia without crisis, Double heterozygous sickling disorders, Sickle-cell trait, Other sickle-cell disorders Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: The allocation of two randomized block blinds is encoded in numbered envelopes and is prepared according to the number of samples and will be provided to the patient's attending physician. Therefore, eligible patients will be randomly divided into a 1: 1 ratio for L-glutamine and hydroxyurea combination therapy or hydroxyurea alone, with randomized block allocation. The planned treatment period will be 6 months, during which patients, in addition to consuming hydroxyurea, take L-glutamine powder orally twice a day at a dose of approximately 0.3 g / kg body weight per dose (10 g, 20 g). Grams or 30 grams [maximum dose] per day). The contents of the package will be mixed with an unheated drink or food and consumed immediately. Patients will be contacted by telephone each week between monthly visits to encourage adherence. The validity of the test group assignment and the correct supply of L-glutamine or placebo for each patient will be verified by an independent research drug service. Patients can receive blood transfusions and other necessary clinical treatments if needed. Control group: The allocation of two randomized block blinds is encoded in numbered envelopes and is prepared according to the number of samples and will be provided to the patient's attending physician. Therefore, eligible patients will be randomly divided into a 1: 1 ratio for L-glutamine and hydroxyurea combination therapy or hydroxyurea alone, with randomized block allocation. The planned treatment period will be 6 months, during which the control group will receive placebo powder (100% maltodextrin) orally twice a day. Experimental drug and placebo in individual packages and visually identical contain 5 grams of white powder without taste is provided, and all packages will be returned by patients to assess compliance. The contents of the package will be mixed with an unheated drink or food and consumed immediately. Patients will be contacted by telephone each week between monthly visits to encourage adherence. The validity of the test group assignment and the correct supply of L-glutamine or placebo for each patient will be verified by an independent research drug service. Patients can receive blood transfusions and other necessary clinical treatments if needed. Number of pain crisis. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist. Number of hospitalizations for pain associated with sickle cell anemia. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist. Number of Priapism event. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist. Number of acute chest syndrome. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist. Number of splenic sequestration events. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Clinical examination by a pediatric hematologist and oncologist. Boushehr University of Medical Sciences Approved 2021-09-19 Research Ethics Committees of Bushehr province university of medical sciences BPUMS Vice chancellery for Education, Bushehr University of Medical Sciences, Salman Farsi St, Alamdar St, Bushehr, Iran. Boushehr Boushehr Iran (Islamic Republic of)