NCT07308769 Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
| NCT ID | NCT07308769 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Pharmanutra S.p.a. |
| Condition | Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 146 participants in total. It began in 2025-12-11 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07308769 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07308769 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07308769 currently recruiting?
Yes, NCT07308769 is actively recruiting participants. Contact the research team at ms.rossato@pharmanutra.it for enrollment information.
Where is the NCT07308769 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain, Barcelona, Spain, Málaga, Spain and 3 additional locations.
Who is sponsoring the NCT07308769 clinical trial?
NCT07308769 is sponsored by Pharmanutra S.p.a.. The trial plans to enroll 146 participants.