drugset / Trial / NCT07308769

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

NCT07308769

Phase 4 Recruiting 146 enrolled Pharmanutra S.p.a.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-12-11
Primary completion
2026-05
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferric maltol Small molecule 60 mg Oral
Subject Sucrosomial Iron Unknown 60 mg Oral