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

NCT06303531 | Enrolling By Invitation

• 1 other identifier: Efficacious Iron
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia

Keywords

Anemia; Iron Deficiency; Ferrous Fumarate; Polysaccharide Iron; Ferrous Ascorbate

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin Levels

  Hemoglobin levels measured using a hematology panel at baseline and 12 weeks

  12 Weeks from Baseline

Secondary Outcomes (2)

• Change in Serum Ferritin

  12 Weeks from Baseline

• Tolerability of Study Medication - Discontinuation Rate

  12 Weeks from Baseline

Study Arms (3)

Eurofer

ACTIVE COMPARATOR

Ferrous Fumarate - 300 mg

Dietary Supplement: Ferrous Fumarate

FeraMAX

ACTIVE COMPARATOR

Polysaccharide Iron - 150mg

Dietary Supplement: Polysaccharide Iron

EBMfer

ACTIVE COMPARATOR

Ferrous Ascorbate - 100 mg

Dietary Supplement: Ferrous Ascorbate

Interventions

Ferrous Fumarate DIETARY_SUPPLEMENT

Ferrous Fumarate - 300 mg

Also known as: Eurofer

Eurofer

Polysaccharide Iron DIETARY_SUPPLEMENT

Polysaccharide Iron - 150 mg

Also known as: FeraMAX

FeraMAX

Ferrous Ascorbate DIETARY_SUPPLEMENT

Ferrous Ascorbate - 100 mg

Also known as: EBMfer

EBMfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be ≥18 years of age when signing the informed consent.
• Participants with iron deficiency anemia are defined as follows for the purpose of this study:

You may not qualify if:

• c. Previously Screen Failed subjects not meeting the \<15 ug/L ferritin criteria can be rescreened once ICF is signed.
• d. Subjects not on iron supplement and meeting all the randomization criteria do not have to wait for 7 days for visit 2.
• \. 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
• Hemoglobin (Hb) ≤ 80 g/L
• 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.).
• 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.
• Medical history or evidence of intestinal malabsorption, malabsorption syndrome, hemochromatosis, and hemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, and gastrojejunostomy.
• History of occult blood in the stool.
• Obvious internal or external bleeding as documented by medical history if considered clinically significant in the investigator's opinion.
• Severe and uncontrolled diseases, including serious psychological disorders, that are likely to interfere with the study.
• Significant co-morbidity, such as a severe chronic medical condition unrelated to iron deficiency that is apparent on history or laboratory tests.
• 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.
• 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).
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Albion Finch Medical Centre

Etobicoke, Ontario, M9V 4B4, Canada

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 28609534 BACKGROUND

• 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.

  PMID: 15646652 BACKGROUND

• Moe S, Grill AK, Allan GM. Newer iron supplements for anemia. Can Fam Physician. 2019 Aug;65(8):556. No abstract available.

  PMID: 31413026 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia; Iron Deficiencies

Interventions

ferrous fumarate; Niferex; Ascorbic Acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 12, 2024
• Study Start: February 24, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

CA (1)