Sucrosomial Iron versus Ferric Maltol for iron-deficiency anemia in women
Official title: A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
Run by Pharmanutra S.p.a. · NCT07308769 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 146 (estimated) |
| Sponsor | Pharmanutra S.p.a. Industry-sponsored |
| Locations | 7 sites (Barcelona and 6 other locations) |
| Status | Recruiting |
| Started | December 11, 2025 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07308769 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 1 more location
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Hospital Quironsalud Zaragoza
Zaragoza, Spain Recruiting
Study contacts
- Study coordinator: Maria Sole Rossato
- Email: ms.rossato@pharmanutra.it
- Phone: +390507846500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.