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IRCT20221231056999N2 IRCT 2023-07-25 DHQ Teaching Hospital Comparison of Oral versus Injectable Iron Chelation Therapy in Reducing Serum Ferritin Levels in Patients with Transfusion Dependent Thalassemia Comparison of Oral versus Injectable Iron Chelation Therapy in Reducing Serum Ferritin Levels in Patients with Transfusion Dependent Thalassemia 2023-08-01 anticipated 50 Complete https://irct.ir/trial/71438 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Children will be randomly divided in two groups by using random number table that will be generated by using Microsoft Excel. 3 Beta thalassemia. Intervention 1: Intervention group: Children will be given oral iron chelation therapy i.e. daily Deferiprone at a dose of 75mg/kg/day in two to three divided doses, for a period of 6-months. Intervention 2: Control group: Children will be given injectable iron chelation therapy i.e. single dose of deferoxamine 4 mmol (225 mg) daily, 6-days a week, for a period of 6-months. 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 Data privacy and secrecy are some of the major concerns related to data sharing of the patients. For now, we are undecided.

public M. Aamir

Street No.1

Bahawalpur Pakistan 63100 +92 321 6801143 aamir@resntec.com RESnTEC, Institute of Research scientific M. Aamir

Street No.1

Bahawalpur Pakistan 63100 +92 321 6801143 aamir@resntec.com RESnTEC, Institute of Research Pakistan Presenting with beta thalassemia major (defined as group of hereditary disorders characterized by a genetic deficiency in the synthesis of beta-globin chains in blood causes severe, transfusion-dependent anemia). Patients who are transfusions dependent with serum ferritin level >2000 ng/ml. 1 year 15 years Both Children already taking trial treatment (as per medical record). Children with liver failure (ALT & AST >50IU). Children having anemia (hemoglobin level <10 g/dl) Children who will lose during follow ups. Parents/Guardian refused the participation of their child. Stoppage of medicine due to side effects/compliance. D56.1 Beta thalassemia Treatment - Drugs Treatment - Drugs Intervention group: Children will be given oral iron chelation therapy i.e. daily Deferiprone at a dose of 75mg/kg/day in two to three divided doses, for a period of 6-months. Control group: Children will be given injectable iron chelation therapy i.e. single dose of deferoxamine 4 mmol (225 mg) daily, 6-days a week, for a period of 6-months. Serum ferritin level. Timepoint: Assessed at baseline and after 6 months of therapy. Method of measurement: Blood sample will be taken by using 3cc disposable syringe and sent to the laboratory of the hospital for assessment of serum ferritin level using standard laboratory protocols. None Approved 2023-04-20 Institutional Ethical Committee Jampur Road Dera Ghazi Khan Punjab Pakistan