Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women (SID-WOMEN)

Pharmanutra S.p.a.

Status and phase: Enrolling; Phase 4

Conditions: Anemia; Iron Deficiency Anemia (IDA)

Treatments: Dietary Supplement: Sucrosomial® Iron (Sideral® Forte); Drug: Ferric Maltol (Feraccru®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07308769

2025-522004-24-00 (EU Trial (CTIS) Number)

SID-WOMEN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Sucrosomial® Iron

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Sucrosomial® Iron (Sideral® Forte)

Ferric Maltol

Active Comparator group

Description:

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).

Treatment:

Drug: Ferric Maltol (Feraccru®)