Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women

Phase 4RecruitingNCT07308769

Pharmanutra S.p.a.146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

146

Conditions

Anemia Iron Deficiency Anemia (IDA)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Hospital Quironsalud Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitari Dexeus Grupo Quironsalud

Barcelona, Spain

RECRUITING

Hospital Universitari Sagrat Cor

Barcelona, Spain

RECRUITING

Hospital Quironsalud Malaga

Málaga, Spain

RECRUITING

Hospital Quironsalud Malága

Málaga, Spain

RECRUITING

Hospital Universitari General De Catalunya

Sant Cugat del Vallès, Spain

RECRUITING

Hospital Quironsalud Zaragoza

Zaragoza, Spain

RECRUITING

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts