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Recruiting NCT07308769

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

Phase IV Interventional Anemia Iron Deficiency Anemia (IDA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sucrosomial® Iron (Sideral® Forte), Ferric Maltol (Feraccru®).
Who it may be relevant to
Registry conditions: Anemia, Iron Deficiency Anemia (IDA). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

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

Primary outcome measures

  • Hemoglobin normalization at week 12 [Time frame: Week 12 (End of Treatment)]
Secondary outcome measures (9)
  • Hemoglobin normalization at intermediate timepoints (Week 6 and Week 8) [Time frame: Week 6 and Week 8]
  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Day 1 to Week 12]
  • Withdrawals due to adverse events [Time frame: Day 1 to Week 12]
  • Treatment discontinuation due to intolerable side effects [Time frame: Day 1 to Week 12]
  • Normalization of iron status markers [Time frame: Baseline to Week 12]
  • Change from baseline in FACIT-Fatigue Scale (v4.0) [Time frame: Day 1, Week 4, Week 6, Week 8, Week 12]
  • Change in hemoglobin levels from baseline at each study visit [Time frame: Baseline to Week 12 (with assessments at Week 6 and Week 8)]
  • Hemoglobin variation in participants with chronic inflammation (CRP-based Subgroups) [Time frame: Baseline to Week 12]
  • Acceptability / discontinuation due to taste [Time frame: Day 1 to Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 7 centers
  • Hospital Quironsalud Barcelona — Barcelona
  • Hospital Universitari Dexeus Grupo Quironsalud — Barcelona
  • Hospital Universitari Sagrat Cor — Barcelona
  • Hospital Quironsalud Malaga — Málaga
  • Hospital Quironsalud Malága — Málaga
  • Hospital Universitari General De Catalunya — Sant Cugat del Vallès
  • Hospital Quironsalud Zaragoza — Zaragoza

Identifiers

NCT: NCT07308769 · SID-WOMEN · 2025-522004-24-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗