NCT05989984

Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia

Monocentric, Prospective, Randomized Study to Evaluate the Efficacy of a New Iron Supplement with Orodispersible Formulation Vs an Iron Supplement in Capsules in Subjects with Mild Anemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: IBSA Farmaceutici Italia Srl · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation vs an iron supplement in capsules in subjects with mild anemia.

Detailed description

The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation in modulating peripheral blood biomarkers of iron levels in subjects with mild anemia after 8 weeks of supplementation, compared to baseline values and also aims to evaluate its acceptability. For the evaluation, an iron supplement in capsules will be used as a comparison supplement.

Conditions

• Iron Deficiencies

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ODF Iron Supplement	ODF iron supplement will be admistered daily for 8 weeks.
DIETARY_SUPPLEMENT	Iron Supplement in Capsules	Iron supplement in capsule will be admistered daily for 8 weeks.

Timeline

• Start date: 2023-07-29
• Primary completion: 2024-08-08
• Completion: 2024-08-08
• First posted: 2023-08-14
• Last updated: 2025-01-08

Locations

1 site across 1 country: Italy