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

RecruitingNAAges 20 Years - anyAllPhramongkutklao College of Medicine and Hospital
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In plain words

What the trial is, and whether it could suit you

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, ope

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female patients aged โ‰ฅ20 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 mยฒ). * 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.
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What it tests

  • Ferrous Fumarate Oral Tablet
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Where

1 site
Phramongkutklao Hospital
Bangkok, Thailand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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