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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eurofer | Active Comparator | Ferrous Fumarate - 300 mg |
|
| FeraMAX | Active Comparator | Polysaccharide Iron - 150mg |
|
| EBMfer | Active Comparator | Ferrous Ascorbate - 100 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Fumarate | Dietary Supplement | Ferrous Fumarate - 300 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Levels | Hemoglobin levels measured using a hematology panel at baseline and 12 weeks | 12 Weeks from Baseline |
| 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. |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albion Finch Medical Centre | Etobicoke | Ontario | M9V 4B4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 28609534 | 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. | |
| 15646652 |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
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| ID | Term |
|---|---|
| C031621 | ferrous fumarate |
| C078972 | Niferex |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Polysaccharide Iron | Dietary Supplement | Polysaccharide Iron - 150 mg |
|
|
| Ferrous Ascorbate | Dietary Supplement | Ferrous Ascorbate - 100 mg |
|
|
| 12 Weeks from Baseline |
| 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. |
| 31413026 | Background | Moe S, Grill AK, Allan GM. Newer iron supplements for anemia. Can Fam Physician. 2019 Aug;65(8):556. No abstract available. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |