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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04130828

Enrollment

Registered

2019-10-17

Start date

2020-01-21

Completion date

2022-01-18

Last updated

2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

ferrous fumarate, oral iron treatment, thrice-weekly, thrice-daily, iron deficiency anemia

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.

Interventions

DRUGFerrous Fumarate

Ferrous fumarate 200 mg PO PC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026