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

NCT07014371 | Recruiting

• 1 other identifier: Hemato-001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Keywords

Iron deficiency anemia; Ferrous fumarate; Alternate day dosing; Hemoglobin

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Level at Week 8 After Oral Iron Supplementation

  Hemoglobin concentration (g/dL) measured at Week 8 following oral ferrous fumarate supplementation. Participants are stratified by sex and baseline Hb level. Comparison between once-daily and alternate-day dosing groups will be analyzed using a linear mixed-effects model.

  8 weeks

Secondary Outcomes (3)

• Change in Reticulocyte Count at Weeks 4 and 8

  4 and 8 weeks

• Change in Serum Ferritin at Weeks 4 and 8

  4 and 8 weeks

• Adverse Effects of Ferrous Fumarate

  During the 8-week treatment period

Study Arms (2)

Once-Daily Dosing Group

ACTIVE COMPARATOR

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.

Drug: Ferrous Fumarate Oral Tablet

Alternate-Day Dosing Group

EXPERIMENTAL

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.

Drug: Ferrous Fumarate Oral Tablet

Interventions

Ferrous Fumarate Oral Tablet 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.

Also known as: Ferrous Fumarate 200 mg tablet, Oral iron supplement

Alternate-Day Dosing Group; Once-Daily Dosing Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

Study Sites (1)

Phramongkutklao Hospital

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous fumarate; Tablets; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

Tanapun Thamgrang, Doctor of Medicine

CONTACT

66859930142; tanapun.tham@pcm.ac.th

Aticha Kraiput, Doctor of Medicine

CONTACT

66862849871; aticha.kr18@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 11, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)