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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Sucrosomial® Iron (Sideral® Forte)
  Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule
• Препарат Ferric Maltol (Feraccru®)
  Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule

Первичные конечные точки

• Hemoglobin normalization at week 12 [Срок оценки: Week 12 (End of Treatment)]

Вторичные конечные точки (9)

• Hemoglobin normalization at intermediate timepoints (Week 6 and Week 8) [Срок оценки: Week 6 and Week 8]
• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Day 1 to Week 12]
• Withdrawals due to adverse events [Срок оценки: Day 1 to Week 12]
• Treatment discontinuation due to intolerable side effects [Срок оценки: Day 1 to Week 12]
• Normalization of iron status markers [Срок оценки: Baseline to Week 12]
• Change from baseline in FACIT-Fatigue Scale (v4.0) [Срок оценки: Day 1, Week 4, Week 6, Week 8, Week 12]
• Change in hemoglobin levels from baseline at each study visit [Срок оценки: Baseline to Week 12 (with assessments at Week 6 and Week 8)]
• Hemoglobin variation in participants with chronic inflammation (CRP-based Subgroups) [Срок оценки: Baseline to Week 12]
• Acceptability / discontinuation due to taste [Срок оценки: Day 1 to Week 12]

Критерии участия

Критерии включения

• Female participants ≥ 18 years
• Mild anemia (11.0 ≤ Hb < 12 g/dL) or moderate anemia (8.0 < Hb < 11 g/dL)
• Signed informed consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 7 центров

• Hospital Quironsalud Barcelona — Barcelona
• Hospital Universitari Dexeus Grupo Quironsalud — Barcelona
• Hospital Universitari Sagrat Cor — Barcelona
• Hospital Quironsalud Malaga — Málaga
• Hospital Quironsalud Malága — Málaga
• Hospital Universitari General De Catalunya — Sant Cugat del Vallès
• Hospital Quironsalud Zaragoza — Zaragoza

Идентификаторы

NCT: NCT07308769 · SID-WOMEN · 2025-522004-24-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗