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

Prince of Songkla University

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia

Treatments: Drug: Ferrous Fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT04130828

REC.62-404-14-1

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Thrice-weekly group

Experimental group

Description:

Ferrous fumarate 200 mg PO PC Thrice-weekly

Treatment:

Drug: Ferrous Fumarate

Thrice-daily group

Active Comparator group

Description:

Ferrous fumarate 200 mg PO PC Thrice-daily

Treatment:

Drug: Ferrous Fumarate