Actively Recruiting
Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
Led by Pharmanutra S.p.a. · Updated on 2026-03-23
146
Participants Needed
7
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Mild anemia with hemoglobin between 11.0 and less than 12 g/dL or moderate anemia with hemoglobin between greater than 8.0 and less than 11 g/dL
- Signed informed consent
You will not qualify if you...
- Use of iron-containing drugs or supplements within 1 month before screening
- Psychiatric disorders that affect consent or compliance
- Active cancer except for 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 before screening
- Need for blood transfusion or intravenous iron as judged by investigator
- Severe active inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Previous bariatric surgery
- Alcohol abuse
- Hemochromatosis or iron overload syndromes
- Hereditary anemias including thalassemia
- Known allergy to ingredients of study products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Hospital Quironsalud Barcelona
Barcelona, Spain, 08023
Actively Recruiting
2
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, Spain, 08028
Actively Recruiting
3
Hospital Universitari Sagrat Cor
Barcelona, Spain, 08029
Actively Recruiting
4
Hospital Quironsalud Malaga
Málaga, Spain, 29004
Actively Recruiting
5
Hospital Quironsalud Malága
Málaga, Spain, 29004
Actively Recruiting
6
Hospital Universitari General De Catalunya
Sant Cugat del Vallès, Spain, 08195
Actively Recruiting
7
Hospital Quironsalud Zaragoza
Zaragoza, Spain, 50006
Actively Recruiting
Research Team
M
Maria Sole Rossato
CONTACT
N
Nataliya Pylypiv
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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