Health TrialsbyHealthPanel

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

ConditionsAnemiaIron Deficiency Anemia (IDA)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sucrosomial® Iron (Sideral® Forte)

    Dietary supplement

    Sucrosomial® Iron (Sideral® Forte), 30 mg elemental iron per capsule

  • Ferric Maltol (Feraccru®)

    Drug

    Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Sucrosomial® IronExperimental treatment 1 intervention
Group B: Ferric MaltolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemoglobin normalization at week 12

Proportion of participants achieving hemoglobin ≥ 12 g/dL after 12 weeks of treatment.

Time frame
Week 12 (End of Treatment)

Secondary outcomes

1

Hemoglobin normalization at intermediate timepoints (Week 6 and Week 8)

Proportion of participants who achieve hemoglobin normalization (Hb ≥ 12 g/dL) at Week 6 and Week 8.

Time frame
Week 6 and Week 8
2

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number and proportion of participants experiencing any AEs or SAEs during the study period, assessed at each visit.

Time frame
Day 1 to Week 12
3

Withdrawals due to adverse events

Number of participants who withdraw from the study because of an adverse event.

Time frame
Day 1 to Week 12
4

Treatment discontinuation due to intolerable side effects

Number of participants who discontinue study treatment due to intolerable side effects.

Time frame
Day 1 to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharmanutra S.p.a.

Lead sponsor

Source ClinicalTrials.gov
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