Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06303531
Other study ID # Efficacious Iron
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 24, 2024
Est. completion date February 2025

Study information

Verified date March 2024
Source Dr. Anil K. Gupta Medicine Professional Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 111
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Dietary Supplement:
Ferrous Fumarate
Ferrous Fumarate - 300 mg
Polysaccharide Iron
Polysaccharide Iron - 150 mg
Ferrous Ascorbate
Ferrous Ascorbate - 100 mg

Locations

Country Name City State
Canada Albion Finch Medical Centre Etobicoke Ontario

Sponsors (1)

Lead Sponsor Collaborator
Dr. Anil K. Gupta Medicine Professional Corporation

Country where clinical trial is conducted

Canada, 

References & 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.

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. — View Citation

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hemoglobin Levels Hemoglobin levels measured using a hematology panel at baseline and 12 weeks 12 Weeks from Baseline
Secondary Change in Serum Ferritin Serum ferritin measured using a hematology panel at baseline and 12 weeks 12 Weeks from Baseline
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06027801 - Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity N/A
Completed NCT02282553 - Gastric Capsule Examination for Iron Deficiency Anaemia N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting NCT04913649 - Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients Phase 4
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Completed NCT01307007 - Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding Phase 2
Completed NCT00982007 - Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA) Phase 3
Completed NCT00198848 - Iron Supplementation Among Adolescent Girls in India N/A
Completed NCT01166451 - The Anemia Control Program: High or Low Iron Supplementation N/A
Recruiting NCT03893045 - A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects Phase 3
Recruiting NCT03817957 - Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency Phase 3
Completed NCT03819530 - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study N/A
Completed NCT03618914 - Anemia and Inflammation
Completed NCT03940430 - Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students Phase 2/Phase 3
Withdrawn NCT03873584 - Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Completed NCT03237065 - Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Phase 3
Completed NCT05153278 - IV Iron Versus Standard Treatment for Iron Deficiency Anemia in the Emergency Department