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Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women

RecruitingPhase 4Ages 18 Years - anyFemalePharmanutra S.p.a.
NCT07308769 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 * Hereditary anemias (including thalassemia) * Known hypersensitivity to study product ingredients
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What it tests

  • Sucrosomial® Iron (Sideral® Forte)
  • Ferric Maltol (Feraccru®)
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Where

7 sites
Hospital Quironsalud Barcelona
Barcelona, Spain
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, Spain
Hospital Universitari Sagrat Cor
Barcelona, Spain
Hospital Quironsalud Malaga
Málaga, Spain
Hospital Quironsalud Malága
Málaga, Spain
Hospital Universitari General De Catalunya
Sant Cugat del Vallès, Spain
Hospital Quironsalud Zaragoza
Zaragoza, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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