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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07483645
Enrollment
74
Registered
2026-03-19
Start date
2025-05-06
Completion date
2026-03-30
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

Anemia, iron supplementation liposomal, hemoblogin, iron deficiency anemia

Brief 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.

Interventions

None listed

Sponsors

Carnot Laboratories
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Hemoglobin level12 weeks

Countries

Mexico

Contacts

PRINCIPAL_INVESTIGATORIris E Torres Garcia, Medico
PRINCIPAL_INVESTIGATORLeonardo R Aguilar, Medico
PRINCIPAL_INVESTIGATORWilly Nava, Medico
PRINCIPAL_INVESTIGATOREdgar U Coronado, Medico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026