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

NCT07308769 | Recruiting Phase 4

• 2 other identifiers: SID-WOMEN2025-522004-24-00
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 7

Brief 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

Iron Deficiency Anemia (IDA); Anemia

Keywords

Iron Deficiency; Iron Deficiency Anemia; Mild to Moderate Anemia; anemia in women

Outcome Measures

Primary Outcomes (1)

• Hemoglobin normalization at week 12

  Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment.

  Week 12 (End of Treatment)

Secondary Outcomes (9)

• Hemoglobin normalization at intermediate timepoints (Week 6 and Week 8)

  Week 6 and Week 8

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 to Week 12

• Withdrawals due to adverse events

  Day 1 to Week 12

• Treatment discontinuation due to intolerable side effects

  Day 1 to Week 12

• Normalization of iron status markers

  Baseline to Week 12

Study Arms (2)

Sucrosomial® Iron

EXPERIMENTAL

Participants will receive dietary supplement Sucrosomial® Iron (Sideral® Forte) for 12 weeks. The dose consists of 60 mg/day of elemental iron (two capsules of Sideral® Forte per day), taken orally on an empty stomach (1 hour before or 2 hours after meals).

Dietary Supplement: Sucrosomial® Iron (Sideral® Forte)

Ferric Maltol

ACTIVE COMPARATOR

Participants in this arm will receive Ferric Maltol (Feraccru®) for 12 weeks. The dose consists of 60 mg/day of ferric maltol (two capsules of Feraccru® per day), taken orally on an empty stomach (1 hour before or 2 hours after meals).

Drug: Ferric Maltol (Feraccru®)

Interventions

Sucrosomial® Iron (Sideral® Forte) DIETARY_SUPPLEMENT

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

Sucrosomial® Iron

Ferric Maltol (Feraccru®) DRUG

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

Ferric Maltol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants ≥ 18 years
• Mild anemia (11.0 ≤ Hb \< 12 g/dL) or moderate anemia (8.0 \< Hb \< 11 g/dL)
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanutra S.p.a.: lead

Study Sites (7)

Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

RECRUITING

Hospital Universitari Dexeus Grupo Quironsalud

Barcelona, 08028, Spain

RECRUITING

Hospital Universitari Sagrat Cor

Barcelona, 08029, Spain

RECRUITING

Hospital Quironsalud Malaga

Málaga, 29004, Spain

RECRUITING

Hospital Quironsalud Malága

Málaga, 29004, Spain

RECRUITING

Hospital Universitari General De Catalunya

Sant Cugat del Vallès, 08195, Spain

RECRUITING

Hospital Quironsalud Zaragoza

Zaragoza, 50006, Spain

RECRUITING

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferric maltol

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Maria Sole Rossato

CONTACT

+390507846500; ms.rossato@pharmanutra.it

Nataliya Pylypiv

CONTACT

+390507846598; n.pylypiv@pharmanutra.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 30, 2025
• Study Start: December 11, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-01

Locations

ES (7)