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Clinical Trials in Spain / NCT07308769
Recruiting Phase 4

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

NCT07308769 · tracked via the Priya Life Science Spain tracker
Sponsor
Pharmanutra S.p.a
Phase
Phase 4
Started
2025-12-11
Last updated
2026-09-03

Condition(s) studied

AnemiaIron Deficiency Anemia (IDA)

Investigational drug(s) / intervention(s)

Sucrosomial® Iron (Sideral® Forte)Ferric Maltol (Feraccru®)

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

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

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female participants ≥ 18 years * Mild anemia (11.0 ≤ Hb \< 12 g/dL) or moderate anemia (8.0 \< Hb \< 11 g/dL) * Signed informed consent Exclusion Criteria: * Use of iron-containing drugs or supplements within 1 month prior to screening * Psychiatric disorders interfering with consent or compliance * Active cancer (except fibroids and polyps) * Pregnant or breastfeeding women * Participation in another interventional study * History of poor adherence or inability to comply * Use of erythropoietin within 3 months prior to screening * Need for blood transfusion or IV iron (per investigator judgment) * Severe active IBD (HBI \> 16 for Crohn; CAI \> 12 for ulcerative colitis) * Previous bariatric surgery * Alcohol abuse * Hemochromatosis or iron overload syndromes * Hereditary anemias (including thalassemia) * Known hypersensitivity to study product ingredients

Primary outcome measure(s)

  • Hemoglobin normalization at week 12 — Week 12 (End of Treatment)
    Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment.

Trial sites (7)

FacilityCityRegionStatus
Hospital Quironsalud Barcelona Barcelona Spain Recruiting
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain Recruiting
Hospital Universitari Sagrat Cor Barcelona Spain Recruiting
Hospital Quironsalud Malaga Málaga Spain Recruiting
Hospital Quironsalud Malága Málaga Spain Recruiting
Hospital Universitari General De Catalunya Sant Cugat del Vallès Spain Recruiting
Hospital Quironsalud Zaragoza Zaragoza Spain Recruiting

Other trials for the same condition

European Rare Blood Disorders Platform (ENROL) Recruiting
FGF23 and Cardiovascular Damage in Anemia With an Without Chronic Kidney Disease. Recruiting
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07308769 on ClinicalTrials.gov ↗ ← All trials in Spain