Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Informapro Srl | OTHER |
Not provided
Not provided
Not provided
The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation vs an iron supplement in capsules in subjects with mild anemia.
The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation in modulating peripheral blood biomarkers of iron levels in subjects with mild anemia after 8 weeks of supplementation, compared to baseline values and also aims to evaluate its acceptability. For the evaluation, an iron supplement in capsules will be used as a comparison supplement.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODF Iron Supplement | Experimental | ODF iron supplement contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 400 μg of folic acid. |
|
| Iron Supplement in Capsule | Active Comparator | Iron supplement in capsule contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 70 mg of vitamin C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ODF Iron Supplement | Dietary Supplement | ODF iron supplement will be admistered daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product) | Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement | Day 0, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood concentration of hemoglobin with test product | Change from baseline in blood concentration of hemoglobin after 4 weeks of supplementation with test product | Day 0, Week 4 |
| Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Silvia Angeletti | Operative Research Unit of Clinical Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Campus Bio-Medico di Roma | Roma | Italy | 00128 | Italy |
Not provided
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| D002214 | Capsules |
| C000718012 | sucrosomial iron |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
Not provided
Not provided
Monocentric, prospective, randomized study
Not provided
Not provided
No masking procedure will be applied
Not provided
| Iron Supplement in Capsules | Dietary Supplement | Iron supplement in capsule will be admistered daily for 8 weeks. |
|
|
Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with Iron supplement in capsule |
| Day 0, Week4, Week 8 |
| Change from baseline in blood concentration of hematocrit | Evalution of the change from baseline of hematocrit after administration of test versus reference product | Day 0, Week4, Week 8 |
| Change from baseline in blood concentration of ferritin | Evalution of the change from baseline of ferritin after administration of test versus reference product | Day 0, Week4, Week 8 |
| Change from baseline in blood concentration of transferrin | Evalution of the change from baseline of transferrin after administration of test versus reference product | Day 0, Week4, Week 8 |
| Change from baseline in blood concentration of transferrin receptor | Evalution of the change from baseline of transferrin receptor after administration of test versus reference product | Day 0, Week4, Week 8 |
| Change from baseline in blood concentration of folic acid | Evalution of the change from baseline of folic acid after administration of test versus reference product | Day 0, Week4, Week 8 |
| Change from baseline in blood concentration of serum iron | Evalution of the change from baseline of serum iron after administration of test versus reference product | Day 0, Week4, Week 8 |
| Change from baseline in mean corpuscolar volume (MCV) | Evalution of the change from baseline of MCV after administration of test versus reference product | Day 0, Week4, Week 8 |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |