Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
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 assigne
| Condition(s) | Anemia, Iron Deficiency Anemia (IDA) |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * Female participants ≥ 18 years * Mild anemia (11.0 ≤ Hb \< 12 g/dL) or moderate anemia (8.0 \< Hb \< 11 g/dL) * Signed informed consent Exclusion Criteria: * Use of iron-containing drugs or supplements within 1 month prior to screening * Psychiatric disorders interfering with consent or compliance * Active cancer (except fibroids and polyps) * Pregnant or breastfeeding women * Participation in another interventional study * History of poor adherence or inability to comply * Use of erythropoietin within 3 months prior to screening * Need for blood transfusion or IV iron (per investigator judgment) * Severe active IBD (HBI \> 16 for Crohn; CAI \> 12 for ulcerative colitis) * Previous bariatric surgery * Alcohol abuse * Hemochromatosis or iron overload syndromes * Heredi |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Pharmanutra S.p.a. |
| Locations | Barcelona, Spain; Barcelona, Spain; Barcelona, Spain; Málaga, Spain; Málaga, Spain; Sant Cugat del Vallès, Spain (+1 more sites) |
| Start date | 2025-12-11 |
| NCT ID | NCT07308769 |
| Official listing | https://clinicaltrials.gov/study/NCT07308769 |