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

Phramongkutklao College of Medicine and Hospital

Status: Enrolling

Conditions: Iron Deficiency Anemia Treatment

Treatments: Drug: Ferrous Fumarate Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07014371

Hemato-001

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Once-Daily Dosing Group

Active Comparator group

Description:

Participants will receive ferrous fumarate 200 mg, taken orally once daily for 8 weeks. This arm represents the standard dosing regimen for treating iron deficiency anemia (IDA). Participants will be monitored at baseline, Week 4, and Week 8 for blood counts, iron parameters, and adverse effects. Medication adherence will be assessed using pill counts.

Treatment:

Drug: Ferrous Fumarate Oral Tablet

Alternate-Day Dosing Group

Experimental group

Description:

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 gastrointestinal side effects compared to daily dosing. Participants will be monitored at baseline, Week 4, and Week 8 for blood counts, iron parameters, and adverse effects. Medication adherence will be assessed using pill counts.

Treatment:

Drug: Ferrous Fumarate Oral Tablet