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Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)

Sponsor: Phramongkutklao College of Medicine and Hospital • ClinicalTrials.gov ID: NCT07014371

Registry updated: 2026-10-14

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Description

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.

Interventions

Ferrous Fumarate Oral Tablet (Drug)
Ferrous 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.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Chronic liver disease including cirrhosis (Child-Pugh class B or C). * Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m²). * Clinically significant thalassemia or hemoglobinopathies. * Ongoing infection or chronic inflammatory diseases (e.g., rheumatoid arthritis, inflammatory bowel disease). * Malabsorption disorders (e.g., history of bariatric surgery). * Red blood cell transfusion within the past 3 months. Withdrawal Criteria * The participant requests to withdraw from the research study. * Hemoglobin level decreases by 1 g/dL or more compared to baseline at Week 4 or Week 8. * Blood hemoglobin level increases by less than 1 g/dL following the evaluation at Week 4 or Week 8, which is considered treatment failure. * Occurrence of severe complications, such as symptomatic anemia or circulatory collapse, requiring intravenous iron therapy or blood transfusion. * Occurrence of severe adverse events that render the participant unable to tolerate oral iron, even after dose reduction. Treatment Failure \- Increase in hemoglobin level of \< 1 g/dL at Week 4 or Week 8 compared with baseline.

Conditions

Iron Deficiency Anemia Treatment

Locations

Phramongkutklao Hospital — Bangkok, Thailand

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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