Thrice-weekly Versus Thrice-daily Oral Ferrous Fumarate Treatment in Adult Patients With Iron Deficiency Anemia
- Registration Number
- NCT04130828
- Lead Sponsor
- Prince of Songkla University
- Brief Summary
Iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. Patients with iron deficiency and Iron deficiency anemia can present with a multitude of symptoms including fatigue, dyspnea on exertion, dysphagia, pallor, palpitations, headaches, tinnitus, taste disturbance and pica. Oral iron supplementation is associated with increasing hemoglobin in multiple studies in women, pregnant women and elderly patients. However, the optimal dose and frequency of oral iron supplementation for treatment remains unclear. The current proposed study attempts to address this gap in the literature.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Age >18 years
- Patients with iron deficiency anemia defined as hemoglobin less than 12 g/dL in women or 13 g/dL in men; AND ferritin less than 30 ng/mL
- Allergy to iron
- Currently pregnancy
- Currently breastfeeding
- Known history of inflammatory bowel disease, celiac disease, inherited bleeding disorder, solid cancer, hematologic cancer or thalassemia
- Renal impairment or glomerular filtration rate less than 30 ml/min/1.73m2
- Hepatic impairment or Child Pugh score more than 7
- Active bleeding define hemoglobin decrease more than 2 g/dL
- Multivitamin and mineral supplement (35 mg or more of elemental iron per day) in 2 weeks prior to randomization
- Non-literate
Subject withdrawal criteria:
- Intolerance to drugs
- Active bleeding define hemoglobin decrease more than 2 g/dL
- Major surgery
- Blood transfusion
- Loss follow-up more than 2 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thrice-daily group Ferrous Fumarate Ferrous fumarate 200 mg PO PC Thrice-daily Thrice-weekly group Ferrous Fumarate Ferrous fumarate 200 mg PO PC Thrice-weekly
- Primary Outcome Measures
Name Time Method Proportion of patient who achieved hemoglobin target 12 weeks Hemoglobin achieved 12 g/dL in women, 13 g/dL in men and or increased 1g/dL/4weeks
- Secondary Outcome Measures
Name Time Method Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events 12 weeks Incidence of Treatment-Emergent Adverse Events
Trial Locations
- Locations (1)
Songklanagarind Hospital
🇹ðŸ‡Hat Yai, Songkhla, Thailand