Actively Recruiting
Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA): A Multicenter, Randomized, Open-Label, Non-Inferiority Trial
Led by Phramongkutklao College of Medicine and Hospital · Updated on 2026-01-07
114
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness and tolerability of two different oral iron dosing schedules in adults with iron deficiency anemia (IDA). The trial aims to determine if taking ferrous fumarate on alternate days is as effective as once-daily dosing in improving hemoglobin levels, while also assessing side effects associated with each regimen. This is a multicenter, randomized, open-label, non-inferiority trial involving adults aged 20 years or older with IDA. Participants are randomly assigned to one of two groups: one takes ferrous fumarate 200 mg once daily for 8 weeks, representing the standard treatment; the other takes 400 mg (two 200 mg tablets) on alternate days for 8 weeks. Both groups are monitored at the start, Week 4, and Week 8 for blood counts, iron parameters, and any adverse effects. Medication adherence is checked by counting remaining pills. During the study, participants will have blood tests and clinical assessments at baseline, Week 4, and Week 8. They will report any side effects and bring leftover medication for adherence evaluation. Researchers will measure hemoglobin levels at Week 8 as the main outcome and also assess changes in reticulocyte count and serum ferritin at Weeks 4 and 8. Safety and side effects will be tracked throughout the 8-week treatment period. The total participation lasts for the 8 weeks of treatment and assessments.
CONDITIONS
Brief Title
Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 20 years or older diagnosed with iron deficiency anemia, defined as hemoglobin less than 13 g/dL in males or less than 12 g/dL in females, and ferritin less than 50 ng/mL or transferrin saturation less than 20%.
- No iron supplementation within the past 3 months.
You will not qualify if you...
- Hemodynamic instability such as acute bleeding or low blood pressure.
- Severe heart failure (NYHA Class III-IV) or other active heart diseases.
- Active cancer 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 with estimated glomerular filtration rate less than 60 mL/min/1.73 m².
- Significant thalassemia or other hemoglobin disorders.
- Ongoing infections or chronic inflammatory diseases like rheumatoid arthritis or inflammatory bowel disease.
- Malabsorption disorders such as history of bariatric surgery.
- Red blood cell transfusion within the past 3 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive ferrous fumarate oral tablets as an iron supplement to treat iron deficiency anemia. They are assigned to take the medication either once daily or two tablets on alternate days for 8 weeks. Participants are monitored for blood counts, iron parameters, and adverse effects during this time.
3 visits (baseline, Week 4, and Week 8)
Trial Site Locations
Total: 1 location
1
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Actively Recruiting
Research Team
T
Tanapun Thamgrang, Doctor of Medicine
A
Aticha Kraiput, Doctor of Medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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