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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
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.
Phramongkutklao Hospital
Bangkok, Thailand
RECRUITINGHemoglobin 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.
Time frame: 8 weeks
Change in Reticulocyte Count at Weeks 4 and 8
Mean change in reticulocyte count (%) from baseline to Week 4 and Week 8.
Time frame: 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.
Time frame: 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.
Time frame: During the 8-week treatment period
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