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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Fumarate Oral Tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Reticulocyte Count at Weeks 4 and 8 | Mean change in reticulocyte count (%) from baseline to Week 4 and Week 8. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria
Treatment Failure
- Increase in hemoglobin level of < 1 g/dL at Week 4 or Week 8 compared with baseline.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanapun Thamgrang, Doctor of Medicine | Contact | 66859930142 | tanapun.tham@pcm.ac.th | |
| Aticha Kraiput, Doctor of Medicine | Contact | 66862849871 | aticha.kr18@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phramongkutklao Hospital | Recruiting | Bangkok | 10400 | Thailand |
Individual participant data (IPD) will not be shared due to institutional policy and privacy concerns. Only aggregate data may be shared upon reasonable request.
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C031621 | ferrous fumarate |
| D013607 | Tablets |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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|
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| 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. | During the 8-week treatment period |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003911 |
| Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |