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

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Winsett Rethman S.A. de C.V.

Monterrey, Nuevo León, 64040, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of iron deficiency anemia.
Candidates over 18 years.
Candidates with Informed Consent signed.
Candidates who have been instructed by their treating physician to start treatment with LISEFEX
Candidates with the ability to swallow substances orally.

Exclusion criteria

Pregnancy or breastfeeding.
Having received any treatment in the last 3 months for iron deficiency anemia.

Treatment and study plan

Primary outcomes

Hemoglobin level

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Carnot Laboratories

Industry

Registry information

Official study title

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.

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 19, 2026
Registry last updated: Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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