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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522004-24-00 | EU Trial (CTIS) Number |
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This study aims to compare two oral iron treatments, Sucrosomial® Iron and Ferric Maltol, in women with mild to moderate iron deficiency anemia. Many patients experience gastrointestinal side effects or poor tolerability with traditional iron supplements, which may limit adherence. Participants will be randomly assigned to receive either Sucrosomial® Iron or Ferric Maltol for 12 weeks. The primary objective is to determine whether Sucrosomial® Iron is as effective as Ferric Maltol in normalizing hemoglobin levels.
This prospective, randomized, open-label, two-arm study evaluates whether Sucrosomial® Iron is non-inferior to Ferric Maltol in normalizing hemoglobin levels over 12 weeks in women with mild to moderate iron deficiency anemia. A total of 146 participants will be randomized 1:1 to receive either Sucrosomial® Iron or Ferric Maltol.
The primary endpoint is hemoglobin normalization at Week 12. Secondary endpoints include changes in iron parameters (serum iron, ferritin, transferrin saturation), fatigue improvement using the FACIT-Fatigue Scale, and assessment of tolerability (adverse events, discontinuations). The study includes a screening phase and follow-up visits at Weeks 4, 6, 8, and 12 for safety monitoring, laboratory assessments, and evaluation of treatment compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sucrosomial® Iron | Experimental | Participants will receive dietary supplement Sucrosomial® Iron (Sideral® Forte) for 12 weeks. The dose consists of 60 mg/day of elemental iron (two capsules of Sideral® Forte per day), taken orally on an empty stomach (1 hour before or 2 hours after meals). |
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| Ferric Maltol | Active Comparator | Participants in this arm will receive Ferric Maltol (Feraccru®) for 12 weeks. The dose consists of 60 mg/day of ferric maltol (two capsules of Feraccru® per day), taken orally on an empty stomach (1 hour before or 2 hours after meals). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrosomial® Iron (Sideral® Forte) | Dietary Supplement | Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin normalization at week 12 | Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment. | Week 12 (End of Treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin normalization at intermediate timepoints (Week 6 and Week 8) | Proportion of participants who achieve hemoglobin normalization (Hb ≥ 12 g/dL) at Week 6 and Week 8. | Week 6 and Week 8 |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Sole Rossato | Contact | +390507846500 | ms.rossato@pharmanutra.it | |
| Nataliya Pylypiv | Contact | +390507846598 | n.pylypiv@pharmanutra.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Quironsalud Barcelona | Recruiting | Barcelona | 08023 | Spain |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D019189 | Iron Metabolism Disorders |
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| ID | Term |
|---|---|
| C062088 | ferric maltol |
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| Ferric Maltol (Feraccru®) | Drug | Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule |
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Number and proportion of participants experiencing any AEs or SAEs during the study period, assessed at each visit. |
| Day 1 to Week 12 |
| Withdrawals due to adverse events | Number of participants who withdraw from the study because of an adverse event. | Day 1 to Week 12 |
| Treatment discontinuation due to intolerable side effects | Number of participants who discontinue study treatment due to intolerable side effects. | Day 1 to Week 12 |
| Normalization of iron status markers | Proportion of participants achieving normalization of iron parameters: serum iron, ferritin, transferrin saturation (TSAT). | Baseline to Week 12 |
| Change from baseline in FACIT-Fatigue Scale (v4.0) | Change from baseline in fatigue symptoms using the FACIT-Fatigue Scale v4.0. Higher scores indicate improvement. | Day 1, Week 4, Week 6, Week 8, Week 12 |
| Change in hemoglobin levels from baseline at each study visit | Mean change in hemoglobin concentration from baseline at each study visit. | Baseline to Week 12 (with assessments at Week 6 and Week 8) |
| Hemoglobin variation in participants with chronic inflammation (CRP-based Subgroups) | Change in hemoglobin levels from baseline in participants stratified by CRP category. CRP values categorized as follows: Normal (CRP < 0.3 mg/dl); Normal or minorelevation (0.3 ≤ CRP < 1.0 mg/dl); Moderate elevation (1.0 ≤ CRP ≤ 10.0 mg/dl); Marked elevation (CRP > 10.0 mg/dl). | Baseline to Week 12 |
| Acceptability / discontinuation due to taste | Proportion of participants refusing or discontinuing the study treatment due to taste. | Day 1 to Week 12 |
| Hospital Universitari Dexeus Grupo Quironsalud | Recruiting | Barcelona | 08028 | Spain |
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| Hospital Universitari Sagrat Cor | Recruiting | Barcelona | 08029 | Spain |
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| Hospital Quironsalud Malaga | Recruiting | Málaga | 29004 | Spain |
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| Hospital Quironsalud Malága | Recruiting | Málaga | 29004 | Spain |
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| Hospital Universitari General De Catalunya | Recruiting | Sant Cugat del Vallès | 08195 | Spain |
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| Hospital Quironsalud Zaragoza | Recruiting | Zaragoza | 50006 | Spain |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |