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

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.

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