Clinical trial NCT07014371: Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
Official title: Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA): A Multicenter, Randomized, Open-Label, Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Iron Deficiency Anemia Treatment
Keywords: Iron deficiency anemia
Ferrous fumarate
Alternate day dosing
Hemoglobin
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hemoglobin Level at Week 8 After Oral Iron Supplementation
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Reticulocyte Count at Weeks 4 and 8
timeFrame: 4 and 8 weeks
measure: Change in Serum Ferritin at Weeks 4 and 8
timeFrame: 4 and 8 weeks
measure: Adverse Effects of Ferrous Fumarate
timeFrame: During the 8-week treatment period
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
References: