A Phase 4 interventional study of Sucrosomial® Iron (Sideral® Forte) and Ferric Maltol (Feraccru®) in Anemia and Iron Deficiency Anemia (IDA), sponsored by Pharmanutra S.p.a.. Recruiting at 7 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Pharmanutra S.p.a. · Phase 4, Interventional, and Treatment
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.
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.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's planned enrollment of 146 is above the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Pharmanutra S.p.a. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Compared within Anemia, Iron-Deficiency, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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®)
Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule
Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule
Hemoglobin normalization at week 12
Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment.
Time frame: Week 12 (End of Treatment)
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.
Time frame: 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.
Time frame: Day 1 to Week 12
Withdrawals due to adverse events
Number of participants who withdraw from the study because of an adverse event.
Time frame: Day 1 to Week 12
Treatment discontinuation due to intolerable side effects
Number of participants who discontinue study treatment due to intolerable side effects.
Time frame: Day 1 to Week 12
Normalization of iron status markers
Proportion of participants achieving normalization of iron parameters: serum iron, ferritin, transferrin saturation (TSAT).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline to Week 12
Acceptability / discontinuation due to taste
Proportion of participants refusing or discontinuing the study treatment due to taste.
Time frame: Day 1 to Week 12
Started Dec 2025 (actual). Primary completion is estimated for Oct 2026, 10 months after the start.
Of 51 phase 4 interventional studies under Anemia, Iron-Deficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 35. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Sucrosomial iron
Pharmanutra S.p.a.