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

March 20, 2026 updated by: Pharmanutra S.p.a.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08023
        • Recruiting
        • Hospital Quironsalud Barcelona
        • Contact:
        • Principal Investigator:
          • Amparo Carrasco Mas, Dr
      • Barcelona, Spain, 08029
        • Recruiting
        • Hospital Universitari Sagrat Cor
        • Contact:
        • Principal Investigator:
          • Erik Johansson, Dr
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitari Dexeus Grupo Quironsalud
        • Contact:
        • Principal Investigator:
          • Andrés Felipe Peña Muñoz, Dr
      • Málaga, Spain, 29004
        • Recruiting
        • Hospital QuironSalud Malaga
        • Contact:
        • Principal Investigator:
          • Ana Carina Silva Klug, Dr
      • Sant Cugat del Vallès, Spain, 08195
        • Recruiting
        • Hospital Universitari General de Catalunya
        • Contact:
        • Principal Investigator:
          • Cesar Velásquez Escandón, Dr
      • Zaragoza, Spain, 50006
        • Recruiting
        • Hospital Quironsalud Zaragoza
        • Contact:
        • Principal Investigator:
          • Sergio Felipe Pinzón Mariño, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin normalization at week 12
Time Frame: Week 12 (End of Treatment)
Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment.
Week 12 (End of Treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 to Week 12
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)
Time Frame: 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
Time Frame: Day 1 to Week 12
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
Time Frame: Day 1 to Week 12
Number of participants who discontinue study treatment due to intolerable side effects.
Day 1 to Week 12
Normalization of iron status markers
Time Frame: Baseline to Week 12
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)
Time Frame: Day 1, Week 4, Week 6, Week 8, Week 12
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
Time Frame: Baseline to Week 12 (with assessments at Week 6 and Week 8)
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)
Time Frame: Baseline to Week 12
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
Time Frame: Day 1 to Week 12
Proportion of participants refusing or discontinuing the study treatment due to taste.
Day 1 to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmanutra S.p.a.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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