NCT07483645

Effectiveness and Acceptability of LISEFEX® (Liposomal Iron With Vitamin C and Fiber) in People With Iron Deficiency Anemia.

Effectiveness and Acceptability of a Liposomal Iron Supplement With Vitamin C and Fiber (LISEFEX®): Observational, Descriptive, Prospective, Longitudinal, Multicenter Study in Mexican Subjects Diagnosed With Mild to Moderate Iron Deficiency Anemia.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Carnot Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Observational, descriptive, prospective, longitudinal, multicenter, non-interventionist and multicentric study in Mexican subjects diagnosed with mild to moderate iron deficiency anemia (ADH). Main objective:To evaluate the effectiveness and acceptability of LISEFEX® supplement in patients with mild to moderate iron deficiency anemia.Design The minimal risk study, no therapeutic interventions were carried out by the research team. The indication for supplementation with LISEFEX® was made by the treating physician as part of standard clinical practice, while the study was limited to systematic collection of clinical and laboratory information during participant follow-up.

Detailed description

The primary objective of this study was to describe the evolution of hemoglobin levels from baseline to weeks 1, 2, 4, 8 and 12 of supplementation with LISEFEX®. Secondary objectives, the aim is to describe various hematological, biochemical and safety parameters throughout the follow-up period in both cohorts. In particular, the percentage of reticulocytes was evaluated basal and in weeks 2, 4, 8 and 12 of supplementation. Also, the values of mean corpuscular volume (MCV), mean corpuscular hemoglobin (HCM) and corpuscular hemoglobin concentration were described mean (CHCM) baseline and follow-up weeks 1, 2, 4, 8, and 12.

Conditions

• Iron Deficiency Anemia

Timeline

• Start date: 2025-05-06
• Primary completion: 2026-02-15
• Completion: 2026-03-30
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Mexico