The goal of this clinical trial is to compare the effectiveness and tolerability of two different oral iron regimens in adults with iron deficiency anemia (IDA). The main questions it aims to answer are:
Is alternate-day oral iron supplementation as effective as once-daily dosing in improving hemoglobin levels?
What are the side effects associated with each dosing regimen?
Researchers will compare once-daily vs. alternate-day oral ferrous fumarate to evaluate whether alternate-day dosing is non-inferior in terms of hematologic response, with fewer adverse effects.
Participants will:
Be randomly assigned to take ferrous fumarate 200 mg once daily or 400 mg on alternate days for 8 weeks
Undergo blood tests and clinical assessments at baseline, Week 4, and Week 8
Report any side effects and bring remaining pills to evaluate medication adherence
This is a multicenter, randomized, open-label, non-inferiority trial conducted in adults aged 20 years or older with IDA.
Male or female patients aged ≥20 years diagnosed with iron deficiency anemia, defined as: hemoglobin (Hb) <13 g/dL in males or <12 g/dL in females, and ferritin <50 ng/mL or transferrin saturation (TSAT) <20%.
No iron supplementation within the past 3 months.
Hemodynamic instability (e.g., acute bleeding or hypotension).
Severe heart failure (New York Heart Association [NYHA] Class III-IV) or other active cardiac diseases.
Active malignancy or history of cancer within the past 3 years (except non-melanoma skin cancer).
Pregnancy or breastfeeding.
Parallel
Ferrous Fumarate Oral Tablet
DrugFerrous fumarate oral tablet 200 mg is an iron supplement used for the treatment of iron deficiency anemia (IDA). In this study, it is administered as either one tablet daily (OD group) or two tablets on alternate days (AD group), with a treatment duration of 8 weeks. The goal is to compare the efficacy and tolerability of alternate-day dosing versus standard once-daily dosing.
Hemoglobin Level at Week 8 After Oral Iron Supplementation
Hemoglobin concentration (g/dL) measured at Week 8 following oral ferrous fumarate supplementation. Participants are stratified by sex and baseline Hb level. Comparison between once-daily and alternate-day dosing groups will be analyzed using a linear mixed-effects model.
Change in Reticulocyte Count at Weeks 4 and 8
Mean change in reticulocyte count (%) from baseline to Week 4 and Week 8.
Change in Serum Ferritin at Weeks 4 and 8
Mean change in serum ferritin concentration (ng/mL) from baseline to Week 4 and Week 8.
Adverse Effects of Ferrous Fumarate
Incidence and type of adverse effects experienced by participants during treatment with ferrous fumarate oral tablets.
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