Sucrosomial Iron versus Ferric Maltol for iron-deficiency anemia in women

A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women

This trial will test whether Sucrosomial Iron works as well as Ferric Maltol to raise hemoglobin in adult women with mild to moderate iron deficiency anemia over 12 weeks.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Pharmanutra S.p.a. (Industry-sponsored)
• Locations: 7 sites (Barcelona and 6 other locations)
• Trial ID: NCT07308769 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, open-label, two-arm Phase 4 trial that will randomize 146 adult women 1:1 to receive either Sucrosomial Iron or Ferric Maltol for 12 weeks. The primary endpoint is hemoglobin normalization at Week 12, with secondary endpoints including serum iron markers, transferrin saturation, ferritin, fatigue measured by the FACIT-Fatigue scale, and tolerability (adverse events and discontinuations). Participants undergo screening and in-person follow-up visits at Weeks 4, 6, 8, and 12 for laboratory assessments, safety monitoring, and treatment compliance checks. The trial compares real-world oral dosing and side-effect profiles to determine if the newer Sucrosomial formulation is non-inferior to Ferric Maltol.

Who should consider this trial

Good fit: Adult women (age ≥18) with mild to moderate iron deficiency anemia who are not pregnant or breastfeeding and can take oral iron and attend clinic visits are ideal candidates.

Not a fit: People with severe anemia requiring transfusion or IV iron, active cancer, hereditary anemias, iron overload disorders, recent bariatric surgery, pregnant or breastfeeding women, or those unable to take oral iron are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a better-tolerated oral iron option that raises hemoglobin with fewer gastrointestinal side effects, improving adherence and symptoms for women with iron deficiency anemia.

How similar studies have performed: Ferric maltol has shown efficacy and tolerability in prior trials and smaller studies of sucrosomial iron suggest improved absorption and GI tolerability, but direct head-to-head data are limited.

Eligibility criteria

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

Where this trial is running

Barcelona and 6 other locations

• Hospital Quironsalud Barcelona — Barcelona, Spain (Recruiting)
• Hospital Universitari Dexeus Grupo Quironsalud — Barcelona, Spain (Recruiting)
• Hospital Universitari Sagrat Cor — Barcelona, Spain (Recruiting)
• Hospital Quironsalud Malaga — Málaga, Spain (Recruiting)
• Hospital Quironsalud Malága — Málaga, Spain (Recruiting)
• Hospital Universitari General De Catalunya — Sant Cugat del Vallès, Spain (Recruiting)
• Hospital Quironsalud Zaragoza — Zaragoza, Spain (Recruiting)

Study contacts

• Study coordinator: Maria Sole Rossato

Conditions Anemia; Iron Deficiency Anemia; Iron Deficiency; Mild to Moderate Anemia; anemia in women