Clinical Trial

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

Study acronym: SID-WOMEN
Recruiting Phase 4
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Record status
This record was last updated March 23, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-12-17; most recent amendment 2026-03-20.
Trial Details
NCT Number NCT07308769
Lead Sponsor Pharmanutra S.p.a.
Conditions Anemia, Iron Deficiency Anemia (IDA)
Enrollment 146 participants
Start Date 2025-12-11
Primary Completion 2026-05 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-23