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

NCT07308769 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Anemia
  • Iron Deficiency Anemia (IDA)

Interventions

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

Sponsors & Collaborators

  • Pharmanutra S.p.a.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2026-05-31
Completion
2026-10-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07308769 on ClinicalTrials.gov