A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women

The primary objective of this study is to determine the efficacy of Sucrosomial® Iron versus Ferric Maltol in achieving the normalization of Hemoglobin (Hb) levels in iron deficient women. This comparison is clinically relevant as it evaluates two distinct oral iron formulations for their capacity to restore hemoglobin concentrations to normal physiological ranges, which is essential for the management of iron deficiency and prevention of associated complications including anemia and impaired oxygen delivery to tissues.

The secondary objectives include:

• To determine the efficacy of Sucrosomial® Iron versus Ferric Maltol in achieving the normalization of Hemoglobin levels at each timepoint

• To assess the tolerability of Sucrosomial® Iron versus Ferric Maltol

• To evaluate the normalization of laboratory values (sideremia, ferritin and TSAT) in patients

• To assess improvement in clinical symptoms of fatigue

• To evaluate the variation in Hemoglobin levels between treatments

• To evaluate Hemoglobin level variation in a subgroup of women with chronic inflammation (according to baseline CRP values)

• To evaluate the acceptability of Sucrosomial® iron versus Ferric Maltol in terms of taste and its impact on treatment continuation

The sponsor did not provide information regarding the total number of participants enrolled in this clinical trial. The study population consisted exclusively of **female subjects** aged 18 years and older, representing adult and elderly age groups. Participants were diagnosed with **iron deficiency** and presented with either **mild anemia** (hemoglobin levels between 11.0 and 12 g/dl) or **moderate anemia** (hemoglobin levels between 8.0 and 11 g/dl). The trial enrolled patients from the general population, and no vulnerable populations were included in the study. All participants provided signed informed consent prior to enrollment. No specific information regarding lifestyle considerations, dietary habits, or physical activity levels was provided by the sponsor.

This is a prospective, open-label, randomized, interventional study designed to evaluate the efficacy and tolerability of two iron supplementation treatments in women with iron deficiency. The trial compares Sucrosomial® Iron with ferric maltol (Feraccru 30 mg hard capsules) administered via oral use. The study follows a Phase IV design and is classified as an interventional clinical trial. The primary objective is to determine the efficacy of Sucrosomial® Iron versus ferric maltol in achieving normalization of hemoglobin levels in iron deficient women. The trial will enroll female participants aged 18 years or older who present with either mild anemia (hemoglobin levels between 11.0 and 12 g/dl) or moderate anemia (hemoglobin levels between 8.0 and 11 g/dl). All participants must provide signed informed consent prior to enrollment.

The primary endpoint is the proportion of patients who achieve hemoglobin normalization, defined as hemoglobin levels ≥ 12 g/dl, at the end of the 12-week treatment period. Secondary endpoints include the proportion of patients achieving hemoglobin normalization at each timepoint, the incidence of adverse events and serious adverse events, the number of patients withdrawing from the study or discontinuing treatment due to side effects, and the proportion of patients achieving normalization of laboratory values including sideremia, ferritin, and TSAT. Additional secondary endpoints assess improvement in clinical symptoms using the FACIT Fatigue Scale version 4.0, differences in hemoglobin level variation from baseline between treatment groups, and specific analysis in the subgroup of women with chronic inflammation based on baseline CRP values. The study also evaluates patient acceptance by measuring the proportion of patients reporting refusal to take the product or discontinuation due to taste.

The maximum treatment period is 12 weeks, with a maximum daily dose of 500 mg/kg and a maximum total dose of 500 mg/kg of the investigational medicinal product. Participant involvement spans from the screening visit through the end-of-study visit following the 12-week treatment period. The sequence of study visits includes an initial screening visit to assess eligibility criteria, followed by scheduled follow-up visits at predetermined timepoints throughout the treatment period to monitor hemoglobin levels, laboratory parameters, clinical symptoms, and safety outcomes. The end-of-study visit occurs at the completion of the 12-week treatment period to evaluate final efficacy and safety measures. Conditions that may lead to early termination from the study include the occurrence of adverse events requiring withdrawal, patient decision to discontinue treatment due to side effects or product tolerability issues, or other safety concerns identified during the course of the trial. The estimated recruitment start date is October 15, 2025, with an estimated end date of October 15, 2026.

The experimental treatment consists of **Feraccru** 30 mg **hard capsules** containing **ferric maltol** as the **active substance** of chemical origin. The pharmaceutical form is a hard capsule formulation intended for **oral use**. The maximum daily dose is 500 mg per kilogram body weight, with a maximum total dose of 500 mg per kilogram body weight. The **treatment period** extends up to 12 weeks. This product is manufactured by NORGINE B.V. and holds marketing authorization under the European Union registration number EU/1/15/1075/004. The medicinal product is classified under **ATC code** B03AB10 and serves as the test treatment in this **open-label**, **randomized**, **interventional study** evaluating efficacy and tolerability in iron deficient women. The study's primary objective is to determine the efficacy of the experimental treatment in achieving normalization of **hemoglobin levels** compared to an alternative iron supplementation regimen.

Efficacy will be assessed through the evaluation of hemoglobin normalization and related hematological parameters in iron deficient women. The primary endpoint is the proportion of patients who achieve hemoglobin normalization, defined as Hb ≥ 12 g/dl, at the end of the 12-week treatment period. Secondary efficacy endpoints include the proportion of patients achieving hemoglobin normalization at each timepoint throughout the study. Laboratory assessments will measure the normalization of sideremia, ferritin, and transferrin saturation (TSAT). Hemoglobin level variation from baseline will be evaluated between treatment groups, both overall and at each timepoint, as well as in a subgroup of women with chronic inflammation based on baseline C-reactive protein (CRP) values. CRP values will be categorized as normal (CRP < 0.3 mg/dl), normal or minor elevation (0.3 ≤ CRP < 1.0 mg/dl), moderate elevation (1.0 ≤ CRP ≤ 10.0 mg/dl), or marked elevation (CRP > 10.0 mg/dl). Clinical symptom improvement will be assessed using the FACIT Fatigue Scale version 4.0. Additional endpoints include the proportion of patients reporting refusal to take the product or discontinuation due to its taste.