Efficacious Iron for Iron Deficiency Anemia in Adults Aged ≥18 Years

An Interventional, Single-Center, Randomized, Unblinded, Parallel-Group, Three-Arm Study to Investigate the Superiority of 12 Weeks of Oral Treatment With Ferrous Ascorbate (EBMfer) or Ferrous Fumarate (Eurofer) as Compared to Polysaccharide Iron (FeraMAX) in Hemoglobin Level Changes in Adults Aged 18 and Above With Iron Deficiency Anemia (EFFICACIOUS IRON)

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06303531

Enrollment

111

Registered

2024-03-12

Start date

2024-02-24

Completion date

2025-02-28

Last updated

2024-03-25

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

Conditions

Iron Deficiency Anemia

Keywords

Anemia, Iron Deficiency, Ferrous Fumarate, Polysaccharide Iron, Ferrous Ascorbate

Brief summary

Iron deficiency anemia (IDA) is a widespread condition affecting many people globally. Despite the many cases of IDA, there are few studies that compare the effectiveness of different types of iron supplements with a greater emphasis on the cost of supplements and their tolerability. This study aims to conduct a comparison between different iron supplements to determine the superiority of the iron supplements Ferrous Ascorbate (EBMfer) and Ferrous Fumarate (Eurofer) over polysaccharide iron (FeraMax). This comparison will be conducted by determining the change in hemoglobin levels for participants in this trial over a 3-month period.

Interventions

DIETARY_SUPPLEMENTFerrous Fumarate

Ferrous Fumarate - 300 mg

DIETARY_SUPPLEMENTPolysaccharide Iron

Polysaccharide Iron - 150 mg

DIETARY_SUPPLEMENTFerrous Ascorbate

Ferrous Ascorbate - 100 mg

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

1. Participants must be ≥18 years of age when signing the informed consent. 2. Participants with iron deficiency anemia are defined as follows for the purpose of this study: Male: Hgb \> 80 to ≤135g/L and Serum Ferritin \< 30 ug/L Female: Hgb \> 80 to ≤120g/L and Serum Ferritin \< 30 ug/L 2b. Local lab done prior to 7 days can be enrolled in the trial provided all the inclusion and

Exclusion criteria

are met. 2c. Previously Screen Failed subjects not meeting the \<15 ug/L ferritin criteria can be rescreened once ICF is signed. 2d. Subjects not on iron supplement and meeting all the randomization criteria do not have to wait for 7 days for visit 2. 3\. Sex and Contraceptive/Barrier Requirements, Male and Female participants: None 4. Must have given written informed consent (signed and dated) 5. Medication Stopping: If the participant is currently on an iron supplement, they must be willing to discontinue the medication upon signing the Informed Consent Form (ICF) and throughout the study. 6. Protocol Compliance: Participants must be able to comply with the requirements outlined in the study protocol

Design outcomes

Primary

Measure	Time frame	Description
Change in Hemoglobin Levels	12 Weeks from Baseline	Hemoglobin levels measured using a hematology panel at baseline and 12 weeks

Secondary

Measure	Time frame	Description
Change in Serum Ferritin	12 Weeks from Baseline	Serum ferritin measured using a hematology panel at baseline and 12 weeks
Tolerability of Study Medication - Discontinuation Rate	12 Weeks from Baseline	Discontinuation rates measured using subject compliance over the trial period of 12 weeks. Discontinuation rate will be measured based on subject compliance with study medication as a rate based on time.

Countries

Canada

Outcome results

None listed

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