RecruitingPhase 4NCT07308769

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


Sponsor

Pharmanutra S.p.a.

Enrollment

146 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ferric Maltol (Feraccru®) and Sucrosomial® Iron (Sideral® Forte) for people with anemia and iron-deficiency anemia (ida). The study is currently recruiting participants at 7 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSucrosomial® Iron (Sideral® Forte)

Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule

DRUGFerric Maltol (Feraccru®)

Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule


Locations(7)

Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital Universitari Dexeus Grupo Quironsalud

Barcelona, Spain

Hospital Universitari Sagrat Cor

Barcelona, Spain

Hospital Quironsalud Malaga

Málaga, Spain

Hospital Quironsalud Malága

Málaga, Spain

Hospital Universitari General De Catalunya

Sant Cugat del Vallès, Spain

Hospital Quironsalud Zaragoza

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT07308769


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