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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Dietary supplement: Ferrous Fumarate; Dietary supplement: Polysaccharide Iron; Dietary supplement: Ferrous Ascorbate

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Etobicoke, Ontario, Canada, M9V 4B4
      • Albion Finch Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

1. Hemoglobin (Hb) ≤ 80 g/L
2. Medical history of current hematological disorders other than iron deficiency anemia (e.g., aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia trait, thalassemia, sickle cell anemia, etc.).
3. Medical history of chronic renal disease, current history of any known inflammatory disorder, and any chronic medical condition that, in the opinion of the Principal Investigator, would compromise participant safety.
4. Medical history or evidence of intestinal malabsorption, malabsorption syndrome, hemochromatosis, and hemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, and gastrojejunostomy.
5. History of occult blood in the stool.
6. Obvious internal or external bleeding as documented by medical history if considered clinically significant in the investigator's opinion.
7. Severe and uncontrolled diseases, including serious psychological disorders, that are likely to interfere with the study.
8. Significant co-morbidity, such as a severe chronic medical condition unrelated to iron deficiency that is apparent on history or laboratory tests.
9. Iron Supplementation: Throughout the study duration, participants are not allowed to receive other sources of iron supplementation, including but not limited to other oral iron tablets and intravenous iron therapy.
10. Prohibited Medication: Inability to withhold prohibited medications. Prohibited medications include Proton Pump Inhibitors, Cholestyramine, colestipol, and new anticoagulant therapy initiated in the past six months (e.g., warfarin, apixaban, dabigatran, edoxaban, rivaroxaban).
11. Multivitamin and Mineral Supplements: Not willing to discontinue multivitamin and mineral supplements containing 35 mg or more of elemental iron per day on the day of screening and throughout the study.
12. Blood Transfusion, Blood Donation, and IV Iron Therapy: History of blood transfusion, blood donation, or significant blood loss (e.g., due to an accident or surgery), or intravenous iron therapy in the past four months.
13. Participants must not be currently participating in any other interventional clinical trial.
14. Pregnancy: A urine dipstick pregnancy test will be performed at Visit 1, and pregnant individuals will be excluded from the study.
15. Desire to Conceive Within the Next 13 weeks: This criterion includes patients who are actively trying to conceive or are receiving treatment to facilitate conception. They will be excluded from the study.
16. Known or Suspected Hypersensitivity to Iron: Individuals with a known or suspected hypersensitivity to iron or any of the components of Ferrous Fumarate (Eurofer), Polysaccharide Iron (FeraMAX), and Ferrous Ascorbate (EBMfer) will be excluded.
17. Planned Surgery: Participants with planned surgery during the study or those who had surgery within two weeks before the screening visit will be excluded.
18. Difficulties with Blood Sampling: Individuals with difficulties related to blood sampling that might hinder the study procedures will be excluded.
19. Alcohol or Drug Abuse: Participants showing evidence of alcohol or drug abuse that, in the opinion of the investigator, could interfere with study compliance or prevent understanding of the study's objectives and procedures will be excluded.
20. Inability to Follow Study Procedures: This includes individuals who are unable to follow study procedures due to factors like language problems or self-reported psychological disorders.
21. Enrollment of the Investigator, Family Members, and Clinic Employees: The investigator, their family members, and clinic employees will not be eligible to participate in the study to avoid any potential conflicts of interest

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eurofer; Ferrous Fumarate - 300 mg	Dietary supplement: Ferrous Fumarate; Ferrous Fumarate - 300 mg; Other Names: Eurofer
Active Comparator: FeraMAX; Polysaccharide Iron - 150mg	Dietary supplement: Polysaccharide Iron; Polysaccharide Iron - 150 mg; Other Names: FeraMAX
Active Comparator: EBMfer; Ferrous Ascorbate - 100 mg	Dietary supplement: Ferrous Ascorbate; Ferrous Ascorbate - 100 mg; Other Names: EBMfer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Ferritin	Serum ferritin measured using a hematology panel at baseline and 12 weeks	12 Weeks from Baseline
Tolerability of Study Medication - Discontinuation Rate	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.	12 Weeks from Baseline

Collaborators and Investigators

• Sponsor: Dr. Anil K. Gupta Medicine Professional Corporation

Publications and helpful links

General Publications

• Powers JM, Buchanan GR, Adix L, Zhang S, Gao A, McCavit TL. Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2297-2304. doi: 10.1001/jama.2017.6846.
• Ganguly S. Comparison between Ferrous Ascorbate and Colloidal Iron in the Treatment of Iron Deficiency Anemia in Children from Kolkata, India. BJMMR 2012; 2: 195-205.
• Liu TC, Lin SF, Chang CS, Yang WC, Chen TP. Comparison of a combination ferrous fumarate product and a polysaccharide iron complex as oral treatments of iron deficiency anemia: a Taiwanese study. Int J Hematol. 2004 Dec;80(5):416-20. doi: 10.1532/ijh97.a10409.
• Moe S, Grill AK, Allan GM. Newer iron supplements for anemia. Can Fam Physician. 2019 Aug;65(8):556. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Anemia; Iron Deficiency; Ferrous Fumarate; Polysaccharide Iron; Ferrous Ascorbate
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases; Iron Deficiencies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Vitamins; Antioxidants; Ferrous fumarate; Ascorbic Acid
• Other Study ID Numbers: Efficacious Iron

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No