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
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
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- 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