AnemiaPhase 4SID-WOMENNCT07308769
Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
A Phase 4 study testing Sucrosomial® Iron (Sideral® Forte) and Ferric Maltol (Feraccru®) in people with Anemia and Iron Deficiency Anemia (IDA), run by Pharmanutra S.p.a. at 7 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anemia, Iron Deficiency Anemia (IDA)
- What is being tested?
- Sucrosomial® Iron (Sideral® Forte) and Ferric Maltol (Feraccru®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 7 sitesSpain
- Study dates
- 11 Dec 2025to Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants ≥ 18 years
- Mild anemia (11.0 ≤ Hb < 12 g/dL) or moderate anemia (8.0 < Hb < 11 g/dL)
- Signed informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Hospital Quironsalud Barcelona
Barcelona, 08023
Amparo Carrasco Mas, Dr., +34932554000, amparocarrasco6@gmail.com
Amparo Carrasco Mas, Dr
- Recruiting
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, 08028
Andrés Felipe Peña Muñoz, Dr., +34932274747, apena@iconcologia.net
Andrés Felipe Peña Muñoz, Dr
- Recruiting
Hospital Universitari Sagrat Cor
Barcelona, 08029
Erik Johansson, Dr., +34933221111, erik.johansson@quironsalud.es
Erik Johansson, Dr
- Recruiting
Hospital Quironsalud Malaga
Málaga, 29004
Rodrigo Orozco Fernández, Dr., +34952176016, rodrigo.orozco@quironsalud.es
Rodrigo Orozco Fernández, Dr
- Recruiting
Hospital Quironsalud Malága
Málaga, 29004
Ana Carina Silva Klug, Dr., +34952176016, ana.silva.co@quironsalud.es
Ana Carina Silva Klug, Dr
- Recruiting
Hospital Universitari General De Catalunya
Sant Cugat del Vallès, 08195
Cesar Velásquez Escandón, Dr., +34935656000, cesar.velasqueze@quironsalud.es
Cesar Velásquez Escandón, Dr
- Recruiting
Hospital Quironsalud Zaragoza
Zaragoza, 50006
Sergio Felipe Pinzón Mariño, Dr., +34976720000, sergiofelipe.pinzon@quironsalud.es
Sergio Felipe Pinzón Mariño, Dr
About this study
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
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.
Read the 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.
- Conditions
- Anemia, Iron Deficiency Anemia (IDA)
- Being tested
- Sucrosomial® Iron (Sideral® Forte), Ferric Maltol (Feraccru®)
- Keywords
- Iron Deficiency, Iron Deficiency Anemia, Mild to Moderate Anemia, anemia in women
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrosomial® Iron (Sideral® Forte)Dietary supplement
Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule
Ferric Maltol (Feraccru®)Drug
Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Ferric Maltol (Feraccru®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin normalization at week 12
Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment.
Measured: Week 12 (End of Treatment)
Secondary outcomes (9)
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.
Measured: Week 6 and Week 8
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.
Measured: Day 1 to Week 12
Withdrawals due to adverse events
Number of participants who withdraw from the study because of an adverse event.
Measured: Day 1 to Week 12
Treatment discontinuation due to intolerable side effects
Number of participants who discontinue study treatment due to intolerable side effects.
Measured: Day 1 to Week 12
Normalization of iron status markers
Proportion of participants achieving normalization of iron parameters: serum iron, ferritin, transferrin saturation (TSAT).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to Week 12
Acceptability / discontinuation due to taste
Proportion of participants refusing or discontinuing the study treatment due to taste.
Measured: Day 1 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start11 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmanutra S.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308769
- Sponsor's protocol ID
- SID-WOMEN
- Other IDs
- 2025-522004-24-00, 2025
- Acronym
- SID-WOMEN
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07308769
- Acronym / sponsor ID
- SID-WOMEN / SID-WOMEN
- Conditions
- Anemia, Iron Deficiency Anemia (IDA)
- Keywords
- Iron Deficiency, Iron Deficiency Anemia, Mild to Moderate Anemia, anemia in women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Pharmanutra S.p.a.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrosomial® Iron | Experimental | Dietary Supplement: Sucrosomial® Iron (Sideral® Forte)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). |
| Ferric Maltol | Active comparator | Drug: Ferric Maltol (Feraccru®)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female participants ≥ 18 years
- Mild anemia (11.0 ≤ Hb < 12 g/dL) or moderate anemia (8.0 < Hb < 11 g/dL)
- Signed informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrosomial® Iron (Sideral® Forte)Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule | Dietary supplement | Sucrosomial® Iron |
| Ferric Maltol (Feraccru®)Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule | Drug | Ferric Maltol |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sucrosomial® Iron (Sideral® Forte) and Ferric Maltol (Feraccru®) in people with Anemia and Iron Deficiency Anemia (IDA), run by Pharmanutra S.p.a. at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Sole Rossato (+390507846500, ms.rossato@pharmanutra.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin normalization at week 12 (time frame: Week 12 (End of Treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.