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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130828
• Other study ID #: REC.62-404-14-1
• Status: Completed
• Phase: Phase 3
• Start date: January 21, 2020
• Est. completion date: January 18, 2022

Study information

• Verified date: February 2022
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Ferrous Fumarate
Ferrous fumarate 200 mg PO PC

Locations

Country	Name	City	State
Thailand	Songklanagarind Hospital	Hat Yai	Songkhla

Sponsors (2)

Lead Sponsor	Collaborator
Prince of Songkla University	The Thai Society of Hematology

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Secondary	Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events	12 weeks