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

NCT ID: NCT07014371

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Iron Deficiency Anemia Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Once-Daily Dosing Group

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.

Group Type: ACTIVE_COMPARATOR

Ferrous Fumarate Oral Tablet

Intervention Type: 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.

Alternate-Day Dosing Group

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.

Group Type: EXPERIMENTAL

Ferrous Fumarate Oral Tablet

Intervention Type: 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.

Interventions

Ferrous Fumarate Oral Tablet

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.

Intervention Type: DRUG

Other Intervention Names

Ferrous Fumarate 200 mg tablet; Oral iron supplement

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

• Withdrawal of informed consent.
• Severe adverse events requiring permanent discontinuation of study medication.
• Investigator's judgment that continued participation poses a safety risk.
• Non-adherence to study medication (compliance < 75%).

Treatment Failure

• Increase in hemoglobin level of < 1 g/dL at Week 4 or Week 8 compared with baseline.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Phramongkutklao Hospital

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Tanapun Thamgrang, Doctor of Medicine

Role: CONTACT

tanapun.tham@pcm.ac.th

66859930142

Aticha Kraiput, Doctor of Medicine

Role: CONTACT

aticha.kr18@gmail.com

66862849871

Facility Contacts

Tanapun Thamgrang, Doctor of Medicine

Role: primary

tanapun.tham@pcm.ac.th

66859930142

Aticha Kraiput, Doctor of Medicine

Role: backup

aticha.kr18@gmail.com

66862849871

Other Identifiers

Hemato-001

Identifier Type: -

Identifier Source: org_study_id