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.
| Registry | NCT07483645 |
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| Status | Active not recruiting |
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| Study type | Observational |
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| Enrollment | 74 (Actual) |
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| Sponsor | Carnot Laboratories (Industry) |
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| Conditions | Iron Deficiency Anemia |
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| Dates | start 2025-05-06, primary completion 2026-02-15, completion 2026-03-30 (estimated), first posted 2026-03-19, last updated 2026-03-19 |
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| Locations | 1 site in Mexico |
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All trials for Iron Deficiency Anemia
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Grupo 1 | | | two sachets of LISEFEX® daily |
| Gurpo 2 | | | two packets of LISEFEX® on alternate days. |
+Outcome measures
Primary outcomes
- Hemoglobin level [12 weeks]
+Eligibility
Sex: All, ages: 18 Years to any
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.
+Locations (1)
| Facility | City | Country | Status |
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| Winsett Rethman S.A. de C.V. | Monterrey, Nuevo León | Mexico | |
+Publications
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- Results publication: Hess SY, McLain AC, Frongillo EA, Afshin A, Kassebaum NJ, Osendarp SJM, Atkin R, Rawat R, Brown KH. Challenges for Estimating the Global Prevalence of Micronutrient Deficiencies and Related Disease Burden: A Case Study of the Global Burden of Disease Study. Curr Dev Nutr. 2021 Nov 18;5(12):nzab141. doi: 10.1093/cdn/nzab141. eCollection 2021 Dec. PMID 34993390
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+Investigators