NCT07308769

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Pharmanutra S.p.a. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Anemia
• Iron Deficiency Anemia (IDA)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sucrosomial® Iron (Sideral® Forte)	Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule
DRUG	Ferric Maltol (Feraccru®)	Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule

Timeline

• Start date: 2025-12-11
• Primary completion: 2026-05-01
• Completion: 2026-10-01
• First posted: 2025-12-30
• Last updated: 2026-03-23

Locations

7 sites across 1 country: Spain