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The study is designed as a parallel, randomized, double blind, three-arm single-center study exploring the efficacy and safety of 12-week once daily oral dosing of iron for correction of overall iron status in 150 otherwise healthy iron-deficient adults presenting with or without mild microcytic anemia. Three iron-containing preparations in the form of either Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, or >Your< Iron Forte Liquid will be tested. Potential study participants will be recruited from the general population of 18-50 year old adults. Participant eligibility will be determined by screening for hemoglobin and ferritin (in combination with C-reactive protein) levels in a sample of venous blood. Eligible individuals will be invited to participate in the study. Enrolled participants will be randomized into one of three intervention groups in a 1:1:1 ratio, receiving either Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, or >Your< Iron Forte Liquid. Efficacy and safety of the assigned interventions will be evaluated through analyses of relevant hematological (hemoglobin, red blood cell indices) and biochemical (ferritin, transferrin saturation) iron-related parameters and reported adverse events after the first 4 and after a total of 12 weeks of intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous Sulfate Capsules | Experimental | 30 mg of elemental iron and 60 mg of vitamin C per capsule. |
|
| >Your< Iron Forte Capsules | Experimental | 30 mg of elemental iron and 60 mg of vitamin C per capsule. |
|
| >Your< Iron Forte Liquid | Experimental | 35 mg of elemental iron, 0.7 mg vitamin B6 and 1.25 mcg vitamin B12 per one dosing (5 ml). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Sulfate Capsules | Dietary Supplement | Once daily dose of one Ferrous Sulfate Capsule for 12 weeks in total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin level from baseline to week 12. | Measurement in a venous blood sample. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin from baseline at week 4. | Measurement in a venous blood sample. | 4 weeks |
| Change in hematocrit from baseline at week 4. | Measurement in a venous blood sample. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrej Kravos, MD, PhD | Private Family Medicine Practice Andrej Kravos, MD, PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diagnostic Laboratory Medicare Plus | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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| >Your< Iron Forte Capsules | Dietary Supplement | Once daily dose of one >Your< Iron Forte Capsule for 12 weeks in total. |
|
| >Your< Iron Forte Liquid | Dietary Supplement | Once daily dose of 5 ml of >Your< Iron Forte Liquid for 12 weeks in total. |
|
| Blank Capsules | Other | Once daily dose of one Blank Capsule (excipients only) for 12 weeks in total. |
|
| Blank Liquid | Other | Once daily dose of 5 ml of Blank Liquid (excipients only) for 12 weeks in total. |
|
| 4 weeks |
| Change in hematocrit from baseline at week 12. | Measurement in a venous blood sample. | 12 weeks |
| Change in mean corpuscular volume from baseline at week 4. | Measurement in a venous blood sample. | 4 weeks |
| Change in mean corpuscular volume from baseline at week 12. | Measurement in a venous blood sample. | 12 weeks |
| Change in mean corpuscular hemoglobin from baseline at week 4. | Measurement in a venous blood sample. | 4 weeks |
| Change in mean corpuscular hemoglobin from baseline at week 12. | Measurement in a venous blood sample. | 12 weeks |
| Change in mean corpuscular hemoglobin concentration from baseline at week 4. | Measurement in a venous blood sample. | 4 weeks |
| Change in mean corpuscular hemoglobin concentration from baseline at week 12. | Measurement in a venous blood sample. | 12 weeks |
| Change in serum ferritin level from baseline at week 4. | Measurement in a venous blood sample. | 4 weeks |
| Change in serum ferritin level from baseline at week 12. | Measurement in a venous blood sample. | 12 weeks |
| Change in transferrin saturation from baseline at week 4. | Measurement in a venous blood sample. | 4 weeks |
| Change in transferrin saturation from baseline at week 12. | Measurement in a venous blood sample. | 12 weeks |
| Collection and assessment of adverse events. | Collection and assessment of adverse events. | 4 weeks |
| Collection and assessment of adverse events. | Collection and assessment of adverse events. | 12 weeks |
| D019189 |
| Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |