Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA) (NCT07014371) | Clinical Trial Compass
RecruitingNot Applicable
Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
Thailand114 participantsStarted 2025-06-09
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hemoglobin Level at Week 8 After Oral Iron Supplementation
Timeframe: 8 weeks
Trial details
NCT IDNCT07014371
SponsorPhramongkutklao College of Medicine and Hospital