Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPharmanutra S.p.a.
About this trial
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.
Eligibility criteria
Qualifiers
Female participants ≥ 18 years
Mild anemia (11.0 ≤ Hb < 12 g/dL) or moderate anemia (8.0 < Hb < 11 g/dL)
Signed informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sucrosomial® Iron (Sideral® Forte)
- Ferric Maltol (Feraccru®)
Treatment groups
146 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov