A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 146
- Locations
- 9
- Primary Endpoint
- Hemoglobin normalization at week 12
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sucrosomial® Iron
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).
Intervention: Sucrosomial® Iron (Sideral® Forte) (Dietary Supplement)
Ferric Maltol
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).
Intervention: Ferric Maltol (Feraccru®) (Drug)
Outcomes
Primary Outcomes
Hemoglobin normalization at week 12
Time Frame: Week 12 (End of Treatment)
Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment.
Secondary Outcomes
- Hemoglobin normalization at intermediate timepoints (Week 6 and Week 8)(Week 6 and Week 8)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 to Week 12)
- Withdrawals due to adverse events(Day 1 to Week 12)
- Treatment discontinuation due to intolerable side effects(Day 1 to Week 12)
- Change from baseline in FACIT-Fatigue Scale (v4.0)(Day 1, Week 4, Week 6, Week 8, Week 12)
- Hemoglobin variation in participants with chronic inflammation (CRP-based Subgroups)(Baseline to Week 12)
- Hemoglobin normalization at intermediate timepoints (Week 6 and Week 8)(Week 6 and Week 8)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 to Week 12)
- Withdrawals due to adverse events(Day 1 to Week 12)
- Treatment discontinuation due to intolerable side effects(Day 1 to Week 12)
- Hemoglobin variation in participants with chronic inflammation (CRP-based Subgroups)(Baseline to Week 12)
- Normalization of iron status markers(Baseline to Week 12)
- Acceptability / discontinuation due to taste(Day 1 to Week 12)
- Change from baseline in FACIT-Fatigue Scale (v4.0)(Day 1, Week 4, Week 6, Week 8, Week 12)
- Change in hemoglobin levels from baseline at each study visit(Baseline to Week 12 (with assessments at Week 6 and Week 8))