Thrice-weekly Versus Thrice-daily Oral Ferrous Fumarate Treatment in Adult Patients With Iron Deficiency Anemia

Prince of Songkla University66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Iron Deficiency Anemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Proportion of patient who achieved hemoglobin target

Hemoglobin achieved 12 g/dL in women, 13 g/dL in men and or increased 1g/dL/4weeks

Time frame: 12 weeks

Secondary Outcomes

Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events

Incidence of Treatment-Emergent Adverse Events