Iron Deficiency Anemia Treatment
Conditions
Keywords
Iron deficiency anemia, Ferrous fumarate, Alternate day dosing, Hemoglobin
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.
Interventions
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.
Sponsors
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Level at Week 8 After Oral Iron Supplementation | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Reticulocyte Count at Weeks 4 and 8 | 4 and 8 weeks | Mean change in reticulocyte count (%) from baseline to Week 4 and Week 8. |
| Change in Serum Ferritin at Weeks 4 and 8 | 4 and 8 weeks | Mean change in serum ferritin concentration (ng/mL) from baseline to Week 4 and Week 8. |
| Adverse Effects of Ferrous Fumarate | During the 8-week treatment period | Incidence and type of adverse effects experienced by participants during treatment with ferrous fumarate oral tablets. |
Countries
Thailand
Contacts
Primary ContactTanapun Thamgrang, Doctor of Medicine
Backup ContactAticha Kraiput, Doctor of Medicine
Outcome results
None listed