Iron Deficiency Anemia TreatmentNCT07014371
Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
A study testing Ferrous Fumarate Oral Tablet in people with Iron Deficiency Anemia Treatment, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Iron Deficiency Anemia Treatment
- What is being tested?
- Ferrous Fumarate Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 9 Jun 2025to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
- The participant requests to withdraw from the research study.
- Hemoglobin level decreases by 1 g/dL or more compared to baseline at Week 4 or Week 8.
- Blood hemoglobin level increases by less than 1 g/dL following the evaluation at Week 4 or Week 8, which is considered treatment failure.
- Occurrence of severe complications, such as symptomatic anemia or circulatory collapse, requiring intravenous iron therapy or blood transfusion.
- Occurrence of severe adverse events that render the participant unable to tolerate oral iron, even after dose reduction.
- Treatment Failure
- Increase in hemoglobin level of < 1 g/dL at Week 4 or Week 8 compared with baseline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Phramongkutklao Hospital
Bangkok, 10400
Tanapun Thamgrang, Doctor of Medicine, 66859930142, tanapun.tham@pcm.ac.th
Aticha Kraiput, Doctor of Medicine, 66862849871, aticha.kr18@gmail.com
About this study
Official title: Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA): A Randomized, Open-Label, Non-Inferiority Trial
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?
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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.
- Conditions
- Iron Deficiency Anemia Treatment
- Being tested
- Ferrous Fumarate Oral Tablet
- Keywords
- Iron deficiency anemia, Ferrous fumarate, Alternate day dosing, Hemoglobin
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Fumarate Oral TabletDrug
Also called Ferrous Fumarate 200 mg tablet, Oral iron supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Once-Daily Dosing Group | Active comparator | Participants will receive ferrous fumarate 200 mg, taken orally once daily for 8 weeks. This arm represents the standard dosing regimen for treating iron deficiency anemia (IDA). Participants will be monitored at baseline, Week 4, and Week 8 for blood counts, iron parameters, and adverse effects. Medication adherence will be assessed using pill counts. Receives: Drug: Ferrous Fumarate Oral Tablet |
| Alternate-Day Dosing Group | Experimental | Participants will receive ferrous fumarate 400 mg (two 200 mg tablets), taken orally on alternate days for 8 weeks. This dosing strategy is being evaluated for improved iron absorption and fewer gastrointestinal side effects compared to daily dosing. Participants will be monitored at baseline, Week 4, and Week 8 for blood counts, iron parameters, and adverse effects. Medication adherence will be assessed using pill counts. Receives: Drug: Ferrous Fumarate Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Level at Week 8 After Oral Iron Supplementation
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.
Measured: 8 weeks
Secondary outcomes (3)
Change in Reticulocyte Count at Weeks 4 and 8
Mean change in reticulocyte count (%) from baseline to Week 4 and Week 8.
Measured: 4 and 8 weeks
Change in Serum Ferritin at Weeks 4 and 8
Mean change in serum ferritin concentration (ng/mL) from baseline to Week 4 and Week 8.
Measured: 4 and 8 weeks
Adverse Effects of Ferrous Fumarate
Incidence and type of adverse effects experienced by participants during treatment with ferrous fumarate oral tablets.
Measured: During the 8-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start9 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014371
- Sponsor's protocol ID
- Hemato-001
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policy and privacy concerns. Only aggregate data may be shared upon reasonable request.