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

Alternate vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA): A Multicenter, Randomized, Open-Label, Non-Inferiority Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250617006
Enrollment
60
Registered
2025-06-17
Start date
2025-06-09
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency anemia treatment anemia, Iron-Deficiency ferrous fumarate

Interventions

Participants will receive ferrous fumarate 400 mg (two 200 mg tablets), taken orally on alternate days for 8 weeks. This dosing strategy is being evaluated for improved iron absorption and fewer gastr
Experimental Drug,Active Comparator Drug
Alternate-Day Dosing Group,Once-Daily Dosing Group

Sponsors

Division of Hematology, Department of Medicine, Phramongkutklao Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 20 years or older diagnosed with iron deficiency anemia defined as hemoglobin less than 13 g/dL in males or less than 12 g/dL in females and ferritin less than 50 ng/mL or transferrin saturation less than 20 percent 2. No iron supplementation within the past 3 months

Exclusion criteria

Exclusion criteria: 1. Hemodynamic instability such as acute bleeding or hypotension 2. Severe heart failure classified as New York Heart Association Class III or IV or other active cardiac diseases 3. Active malignancy or history of cancer within the past 3 years except nonmelanoma skin cancer 4. Pregnancy or breastfeeding 5. Chronic liver disease including cirrhosis classified as Child-Pugh class B or C 6. Chronic kidney disease with estimated glomerular filtration rate less than 60 mL per minute per 1.73 square meters 7. Clinically significant thalassemia or hemoglobinopathies 8. Ongoing infection or chronic inflammatory diseases such as rheumatoid arthritis or inflammatory bowel disease 9. Malabsorption disorders including history of bariatric surgery 10. Red blood cell transfusion within the past 3 months

Design outcomes

Primary

MeasureTime frame
Hemoglobin Level Week 4 and 8 Blood for complete blood count (CBC). Hemoglobin concentration measured at Week 4 and 8 following oral ferrous fumarate supplementation.

Secondary

MeasureTime frame
Reticulocyte Count Week 4 and 8 Blood for reticulocyte count. Change in Reticulocyte Count at Weeks 4 and 8,Serum Ferritin Week 4 and 8 Blood for serum ferritin. Change in Serum Ferritin at Weeks 4 and 8,Adverse Effects of Ferrous Fumarate During the 8-week treatment period Incidence and type of adverse effects experienced by participants during treatment with ferrous fumarate oral tablets.

Countries

Thailand

Contacts

Public ContactTanapun Thamgrang

Phramongkutklao Hospital

tanapun.tham@pcm.ac.th0863089312

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026