Iron Deficiency anemia. Iron deficiency anemia
Conditions
Interventions
Intervention 1: Intervention group: Licensed brand Irofix Forte (oral iron drops
higher-cost brand), administered daily for one month according to the standard global treatment regimen: 15 mg of elemental iron per day (adjusted based on WHO 2016 recommendations). Manufacturer: Omi
lower-cost brand), administered daily for one month according to the treatment regimen commonly used in Iran and aligned with the standard global treatment protocol: 14 mg of elemental iron per day (a
Sponsors
Islamic Azad University
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of mild to moderate iron deficiency anemia (IDA): defined as a hemoglobin (Hb) level below 11 g/dL, according to the relevant age- and sex-specific reference ranges. Absence of chronic diseases Obtaining written informed consent from the parents or legal guardians
Exclusion criteria
Exclusion criteria: Presence of chronic diseases affecting iron metabolism (such as thalassemia, hemolytic anemias, and chronic kidney disease). Known hypersensitivity or intolerance to iron supplements. Requirement for intravenous iron therapy or blood transfusion within the past one month or during the study period. Lack of consent from the parents or legal guardians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood hemoglobin (Hb) level. Timepoint: Measurement of blood hemoglobin (Hb) level at baseline (Day 0) and one month (30 days) after initiation of iron drop supplementation (start of treatment). Method of measurement: Complete Blood Count (CBC) Test.;Cost of purchasing oral iron drops for treatment. Timepoint: Frequency of purchase: one bottle per week (the iron drops are procured by the investigator [Mohammad Bidi] and provided to the patients). Method of measurement: Official approved price as listed in the TTAC system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Indirect costs of treatment (laboratory tests, physician visits, and management of adverse effects, etc.). Timepoint: Assessed over a one-month period. Method of measurement: Based on official pharmacy and hospital invoices and parents’ reports (questionnaire completed at the end of one month).;Adverse effects resulting from the use of iron drops. Timepoint: Assessed over a one-month period. Method of measurement: Questionnaire obtained from parents at the end of one month of treatment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Bidi
Islamic Azad University
Outcome results
None listed