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

Sponsor

Prince of Songkla University (Other)

Overall Status

Completed

CT.gov ID

NCT04130828

Collaborator

The Thai Society of Hematology (Other)

Enrollment

Location

Arms

23.9

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia	Drug: Ferrous Fumarate	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 21, 2020

Actual Primary Completion Date :

Jan 18, 2022

Actual Study Completion Date :

Jan 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thrice-weekly group Ferrous fumarate 200 mg PO PC Thrice-weekly	Drug: Ferrous Fumarate Ferrous fumarate 200 mg PO PC
Active Comparator: Thrice-daily group Ferrous fumarate 200 mg PO PC Thrice-daily	Drug: Ferrous Fumarate Ferrous fumarate 200 mg PO PC

Arm

Intervention/Treatment

Experimental: Thrice-weekly group

Ferrous fumarate 200 mg PO PC Thrice-weekly

Drug: Ferrous Fumarate

Ferrous fumarate 200 mg PO PC

Active Comparator: Thrice-daily group

Ferrous fumarate 200 mg PO PC Thrice-daily

Drug: Ferrous Fumarate

Ferrous fumarate 200 mg PO PC

Outcome Measures

Primary Outcome Measures

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

Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events [12 weeks]
Incidence of Treatment-Emergent Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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