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IRCT20151020024625N17 IRCT 2023-04-15 Semnan University of Medical Sciences Effectiveness of liposomal and ferrous iron in the treatment of iron deficiency Comparison of the effectiveness of liposomal and ferrous iron in the treatment of iron deficiency in infants and children 2023-05-05 anticipated 60 Complete https://irct.ir/trial/69479 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, at first stage, 60 spheres from one to 60 are considered and following that will randomly divided into two equal parts, including "1" (Intervention1) and group 2 (Intervention2), and then using a lottery container, the ball of each group taken out and the intended sequence will be recorded, Blinding description: The blinding of the study is such that the care provider, outcome assessor and biostatistician do not know the content of the intervention. For administration, the drug will be given to the clinical care provider for administration by mentioning the administration method. The outcome assessor records the outcome based on the patient's identity number according to the randomization table, and the data collected based on the number and mention of the first and second intervention is provided to the biostatistician for analysis. 4 Condition 1: Iron deficiency. Condition 2: Iron deficiency anemia. Intervention 1: Intervention group: The liposomal iron, equivalent to 6 mg/kg/day of elemental iron is prescribed with a maximum dose of 200 mg/day. Intervention 2: Control group: The ferrous iron equivalent to 6 mg/kg/day of elemental iron is prescribed with a maximum dose of 200 mg/day. Yes - There is a plan to make this available What will be shared: All data will be presented anonymously. When: After publishing of the results, the data will be delivered upon request and after verification. To whom: The data will be available only for academic researchers. Conditions: In order to conduct similar studies. Where to obtain: Direct request from the scientific responsible. How to obtain: After request and authentication, the data will be provided. Comments:
public Maryam Nomani
No. 9771, Shahid Mostafa Khomeini Blvd.
Semnan Iran (Islamic Republic of) 34731-35197 +98 23 3346 0055 maryam.nomani@gmail.com Semnan University of Medical Sciences scientific Mehri Ayati
No. 9771, Shahid Mostafa Khomeini Blvd.
Semnan Iran (Islamic Republic of) 34731-35197 +98 23 3346 0055 yar.mehrnoosh@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with iron deficiency and iron deficiency anemia 6 months 2 years Both A history for use of iron supplements Hemoglobinopathy Severe anemia or anemia due to other causes Asthma Malignancy Active infection Renal dysfunction E61.1 D50.8 Iron deficiency Other iron deficiency anemias Treatment - Drugs Treatment - Drugs Intervention group: The liposomal iron, equivalent to 6 mg/kg/day of elemental iron is prescribed with a maximum dose of 200 mg/day. Control group: The ferrous iron equivalent to 6 mg/kg/day of elemental iron is prescribed with a maximum dose of 200 mg/day. Serum Iron. Timepoint: Before and 4 and 12 weeks after intervention. Method of measurement: Biochemical test. Ferritin. Timepoint: Before and 4 and 12 weeks after intervention. Method of measurement: Biochemical test. Total Iron-Binding Capacity. Timepoint: Before and 4 and 12 weeks after intervention. Method of measurement: Biochemical test. Hemoglubin. Timepoint: Before and 4 and 12 weeks after intervention. Method of measurement: Hematological test. Hematocrit. Timepoint: Before and 4 and 12 weeks after intervention. Method of measurement: Hematological test. Semnan University of Medical Sciences Approved 2021-12-28 Ethics Committee of Semnan University of Medical Sciences Basidj Blvd. Semnan Semnan Iran (Islamic Republic of)