Alternate-day versus once-daily oral iron for iron deficiency anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, non-inferiority trial comparing two oral ferrous fumarate regimens in adults with iron deficiency anemia. Participants are assigned to either 200 mg once daily or 400 mg on alternate days for 8 weeks, with blood tests and clinical assessments at baseline, Week 4, and Week 8. The trial measures hematologic response (hemoglobin and iron indices), side effects, and medication adherence to see if alternate-day dosing provides similar benefit with better tolerability. The multicenter design aims to capture real-world adherence and adverse event profiles.

Why it matters

Who can join: the full rules

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.

Where it's running

• Phramongkutklao Hospital
  Bangkok, Thailand Recruiting

Study contacts

• Study coordinator: Tanapun Thamgrang, Doctor of Medicine
• Email: tanapun.tham@pcm.ac.th
• Phone: 66859930142

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving blood management for patients undergoing heart surgery

  This study is testing if giving patients iron before heart surgery can help them recover better and need fewer blood transfusions.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT06637137

• Iron treatment for children and young adults with Crohn’s disease and iron deficiency anemia

  This study tests how different iron treatment approaches work for kids and young adults with Crohn’s disease and iron deficiency anemia.

  Recruiting Phase 4 Weill Medical College of Cornell University · New York, New York · NCT07925450

• Donor Breast Milk with Early Iron Supplementation in Very Preterm Infants

  In very preterm babies who mainly receive donor breast milk, this study tests whether starting iron supplementation earlier (around when feeding reaches 80 ml/kg/day) can raise ferritin and hematocrit levels by days 14 and 28.

  Recruiting AdventHealth · Orlando, Florida · NCT07816601

• Preconception versus early-pregnancy iron screening and treatment

  This trial tests whether screening and treating iron deficiency before conception is better than starting screening and iron treatment in early pregnancy for preventing iron deficiency anemia later in pregnancy.

  Recruiting Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Zhaotong, Yunnan · NCT07811765

• Ferric derisomaltose injection in adults with iron deficiency anemia under fasting conditions

  This study tests whether a ferric derisomaltose injection given to adults with iron deficiency anemia in a fasting state works similarly to a reference product and is safe to use.

  Recruiting Phase 1 Sichuan Huiyu Pharmaceutical Co., Ltd · Zhengzhou · NCT07790562

• FACE-APPS approach to improve iron in adolescent girls in marginalized communities

  This study tests a blended program of face-to-face counseling and mobile app activities to see if it improves iron levels in adolescent girls with iron deficiency.

  Recruiting Cairo University · Wadi Addawasir, Wadi Addawasir Governorate · NCT07633262

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.