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Oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. These supplements typically contain various iron salts, such as ferrous sulfate, ferric maltol, ferrous gluconate, and ferric pyrophosphate.
Advancements in carrier systems, such as microencapsulation or complexation can enhance the absorption and bioavailability of iron supplements. By improving absorption, these carrier systems may mitigate gastrointestinal side effects and increase the efficacy of iron therapy.
This multicenter, randomized, double-blind parallel-group, clinical trial study aims to conduct a comparative analysis of the effectiveness of oral ferric maltose, vs Sucrosomial iron. The study seeks to evaluate their efficacy in treating iron deficiency or iron deficiency anemia, two prevalent conditions associated with low iron levels in the body. This research aims to provide valuable insights into potential difference in these two iron supplement formulations, both in terms of relative effectiveness and potential GI side effects. This comparative analysis may guide healthcare providers in selecting the most suitable oral iron supplement based on individual patient characteristics, ultimately optimizing treatment outcomes and improving patient care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm 1 | Experimental | Subjects in this arm will receive an oral Sucrosomial 30mg elemental iron supplement, twice daily, for 6 weeks. |
|
| Intervention Arm 2 | Active Comparator | Subjects in this arm will receive an oral Ferric maltol 30mg elemental iron supplement, twice daily, for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Sucrosomial iron | Dietary Supplement | 30 mg capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the serum iron concentration | Increase in the circulatory iron levels | 6 weeks |
| Changes in the serum ferritin concentration | Increase in the circulatory ferritin levels | 6 weeks |
| Change in blood Hemoglobin (Hb) levels | Increase in the blood (Hb) levels | 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of gastrointestinal side effects | Incidence of treatment-emergent gastrointestinal side effects | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Hospital | Lahore | Punjab Province | 54000 | Pakistan | ||
| DHQ Hospital Narowal |
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| Oral Ferric maltol |
| Dietary Supplement |
30 mg capsule |
|
| Narowal |
| Punjab Province |
| 51600 |
| Pakistan |
| Civil Hospital Kotri Distt Jamshoro | Kotri | Sindh | 76000 | Pakistan |
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000718012 | sucrosomial iron |
| C062088 | ferric maltol |
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