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NCT Number: NCT07014371

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location status: Recruiting

Location contact

Aticha Kraiput, Doctor of Medicine

CONTACT

[email protected]

66862849871

Aticha Kraiput, Doctor of Medicine

PRINCIPAL_INVESTIGATOR

Tanapun Thamgrang, Doctor of Medicine

CONTACT

[email protected]

66859930142

Tanapun Thamgrang, Doctor of Medicine

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ferrous Fumarate 200 mg tablet, Oral iron supplement

Primary outcomes

  1. Hemoglobin Level at Week 8 After Oral Iron Supplementation

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Change in Reticulocyte Count at Weeks 4 and 8

    Time frame: 4 and 8 weeks

    Mean change in reticulocyte count (%) from baseline to Week 4 and Week 8.

  2. Change in Serum Ferritin at Weeks 4 and 8

    Time frame: 4 and 8 weeks

    Mean change in serum ferritin concentration (ng/mL) from baseline to Week 4 and Week 8.

  3. Adverse Effects of Ferrous Fumarate

    Time frame: During the 8-week treatment period

    Incidence and type of adverse effects experienced by participants during treatment with ferrous fumarate oral tablets.

Study contacts

Contact information is provided by the study sponsor or research team.

Aticha Kraiput, Doctor of Medicine

CONTACT

[email protected]

66862849871

Tanapun Thamgrang, Doctor of Medicine

CONTACT

[email protected]

66859930142

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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