Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women (SID-WOMEN)

A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; Iron Deficiency Anemia (IDA)
• Intervention / Treatment: Dietary supplement: Sucrosomial® Iron (Sideral® Forte); Drug: Ferric Maltol (Feraccru®)

Detailed Description

This prospective, randomized, open-label, two-arm study evaluates whether Sucrosomial® Iron is non-inferior to Ferric Maltol in normalizing hemoglobin levels over 12 weeks in women with mild to moderate iron deficiency anemia. A total of 146 participants will be randomized 1:1 to receive either Sucrosomial® Iron or Ferric Maltol.

The primary endpoint is hemoglobin normalization at Week 12. Secondary endpoints include changes in iron parameters (serum iron, ferritin, transferrin saturation), fatigue improvement using the FACIT-Fatigue Scale, and assessment of tolerability (adverse events, discontinuations). The study includes a screening phase and follow-up visits at Weeks 4, 6, 8, and 12 for safety monitoring, laboratory assessments, and evaluation of treatment compliance.

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maria Sole Rossato; Phone Number: +390507846500; Email: ms.rossato@pharmanutra.it
• Study Contact Backup: Name: Nataliya Pylypiv; Phone Number: +390507846598; Email: n.pylypiv@pharmanutra.it

Study Locations

• Spain
  • Barcelona, Spain, 08023
    • Recruiting
    • Hospital Quironsalud Barcelona
    • Contact: Amparo Carrasco Mas, Dr.; Phone Number: +34932554000; Email: amparocarrasco6@gmail.com
    • Principal Investigator: Amparo Carrasco Mas, Dr
  • Barcelona, Spain, 08029
    • Recruiting
    • Hospital Universitari Sagrat Cor
    • Contact: Erik Johansson, Dr.; Phone Number: +34933221111; Email: erik.johansson@quironsalud.es
    • Principal Investigator: Erik Johansson, Dr
  • Barcelona, Spain, 08028
    • Recruiting
    • Hospital Universitari Dexeus Grupo Quironsalud
    • Contact: Andrés Felipe Peña Muñoz, Dr.; Phone Number: +34932274747; Email: apena@iconcologia.net
    • Principal Investigator: Andrés Felipe Peña Muñoz, Dr
  • Málaga, Spain, 29004
    • Recruiting
    • Hospital Quironsalud Malaga
    • Contact: Ana Carina Silva Klug, Dr.; Phone Number: +34952176016; Email: ana.silva.co@quironsalud.es
    • Principal Investigator: Ana Carina Silva Klug, Dr
  • Sant Cugat del Vallès, Spain, 08195
    • Recruiting
    • Hospital Universitari General de Catalunya
    • Contact: Cesar Velásquez Escandón, Dr.; Phone Number: +34935656000; Email: cesar.velasqueze@quironsalud.es
    • Principal Investigator: Cesar Velásquez Escandón, Dr
  • Zaragoza, Spain, 50006
    • Recruiting
    • Hospital QuirónSalud Zaragoza
    • Contact: Sergio Felipe Pinzón Mariño, Dr.; Phone Number: +34976720000; Email: sergiofelipe.pinzon@quironsalud.es
    • Principal Investigator: Sergio Felipe Pinzón Mariño, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sucrosomial® Iron; 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); Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule
Active Comparator: Ferric Maltol; 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®); Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin normalization at week 12	Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment.	Week 12 (End of Treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number and proportion of participants experiencing any AEs or SAEs during the study period, assessed at each visit.	Day 1 to Week 12
Hemoglobin normalization at intermediate timepoints (Week 6 and Week 8)	Proportion of participants who achieve hemoglobin normalization (Hb ≥ 12 g/dL) at Week 6 and Week 8.	Week 6 and Week 8
Withdrawals due to adverse events	Number of participants who withdraw from the study because of an adverse event.	Day 1 to Week 12
Treatment discontinuation due to intolerable side effects	Number of participants who discontinue study treatment due to intolerable side effects.	Day 1 to Week 12
Normalization of iron status markers	Proportion of participants achieving normalization of iron parameters: serum iron, ferritin, transferrin saturation (TSAT).	Baseline to Week 12
Change from baseline in FACIT-Fatigue Scale (v4.0)	Change from baseline in fatigue symptoms using the FACIT-Fatigue Scale v4.0. Higher scores indicate improvement.	Day 1, Week 4, Week 6, Week 8, Week 12
Change in hemoglobin levels from baseline at each study visit	Mean change in hemoglobin concentration from baseline at each study visit.	Baseline to Week 12 (with assessments at Week 6 and Week 8)
Hemoglobin variation in participants with chronic inflammation (CRP-based Subgroups)	Change in hemoglobin levels from baseline in participants stratified by CRP category. CRP values categorized as follows: Normal (CRP < 0.3 mg/dl); Normal or minorelevation (0.3 ≤ CRP < 1.0 mg/dl); Moderate elevation (1.0 ≤ CRP ≤ 10.0 mg/dl); Marked elevation (CRP > 10.0 mg/dl).	Baseline to Week 12
Acceptability / discontinuation due to taste	Proportion of participants refusing or discontinuing the study treatment due to taste.	Day 1 to Week 12

Collaborators and Investigators

• Sponsor: Pharmanutra S.p.a.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Iron Deficiency Anemia; Iron Deficiency; Mild to Moderate Anemia; anemia in women
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia; Anemia, Iron-Deficiency; ferric maltol
• Other Study ID Numbers: SID-WOMEN; 2025-522004-24-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No