A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Female participants ≥ 18 years
• Mild anemia (11.0 ≤ Hb \< 12 g/dL) or moderate anemia (8.0 \< Hb \< 11 g/dL)
• Signed informed consent
Locations
Other Locations
Spain
Hospital Quironsalud Barcelona
RECRUITING
Barcelona
Hospital Universitari Dexeus Grupo Quironsalud
RECRUITING
Barcelona
Hospital Universitari Sagrat Cor
RECRUITING
Barcelona
Hospital Quironsalud Malaga
RECRUITING
Málaga
Hospital Quironsalud Malága
RECRUITING
Málaga
Hospital Universitari General De Catalunya
RECRUITING
Sant Cugat Del Vallès
Hospital Quironsalud Zaragoza
RECRUITING
Zaragoza
Contact Information
Primary
Maria Sole Rossato
ms.rossato@pharmanutra.it
+390507846500
Backup
Nataliya Pylypiv
n.pylypiv@pharmanutra.it
+390507846598
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2026-10
Participants
Target number of participants: 146
Treatments
Experimental: Sucrosomial® Iron
Participants will receive dietary supplement Sucrosomial® Iron (Sideral® Forte) for 12 weeks.~The dose consists of 60 mg/day of elemental iron (two capsules of Sideral® Forte per day), taken orally on an empty stomach (1 hour before or 2 hours after meals).
Active_comparator: Ferric Maltol
Participants in this arm will receive Ferric Maltol (Feraccru®) for 12 weeks. The dose consists of 60 mg/day of ferric maltol (two capsules of Feraccru® per day), taken orally on an empty stomach (1 hour before or 2 hours after meals).
Related Therapeutic Areas
Sponsors
Leads: Pharmanutra S.p.a.