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

March 17, 2026 updated by: Carnot Laboratories

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64040
        • Winsett Rethman S.A. de C.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Mexican population in the usual clínica

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Grupo 1
two sachets of LISEFEX® daily
Gurpo 2
two packets of LISEFEX® on alternate days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin level
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carnot Laboratories

Investigators

  • Principal Investigator: Iris E Torres Garcia, Medico
  • Principal Investigator: Leonardo R Aguilar, Medico
  • Principal Investigator: Willy Nava, Medico
  • Principal Investigator: Edgar U Coronado, Medico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • World Health Organization. (2024). Guideline on haemoglobin cutoffs to define anaemia in individuals and populations. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.
  • Waldvogel-Abramowski S, Waeber G, Gassner C, Buser A, Frey BM, Favrat B, Tissot JD. Physiology of iron metabolism. Transfus Med Hemother. 2014 Jun;41(3):213-21. doi: 10.1159/000362888. Epub 2014 May 12. PMID: 25053935; PMCID: PMC4086762.
  • von Siebenthal, H.K., Gessler, S., Vallelian, F., Steinwendner, J., Kuenzi, U., Moretti, D., Zimmermann M.B., Stoffel, N.U. (2023). Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. eClinical Medicine 65. https://doi.org/10.1016/j.eclinm.2023.102286
  • Uçan A, Kaya ZI, Yilmaz EÖ, Vasi İ, Özgeyik MO. Comparing therapeutic effects of alternate day versus daily oral iron in women with iron deficiency anemia: A retrospective cohort study. Medicine (Baltimore). 2023 Jul 28;102(30):e34421. doi: 10.1097/MD.0000000000034421. PMID: 37505179; PMCID: PMC10378732.
  • Stoffel N.U., Zeder, C., Brittenham, G.M., Moretti D., Zimmerman M.B. (2020). Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica, 105 (5).
  • Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. doi: 10.1093/ndt/gfu357. Epub 2014 Nov 13. PMID: 25395392.
  • Obeagu EI, Obeagu GU, Ukibe NR, Oyebadejo SA. Anemia, iron, and HIV: decoding the interconnected pathways: A review. Medicine (Baltimore). 2024 Jan 12;103(2):e36937. doi: 10.1097/MD.0000000000036937. PMID: 38215133; PMCID: PMC10783375.
  • Mejía-Rodríguez F, Mundo-Rosas V, García-Guerra A, Mauricio-López ER, Shamah-Levy T, Villalpando S, De la Cruz-Góngora V. Prevalencia de anemia en la población mexicana:análisis de la Ensanut Continua 2022. Salud Publica Mex. 2023;65(supl 1):S225-S230. https://doi.org/10.21149/14771
  • Mastrogiannaki MMP, Matak P, Peyssonnaux C. The gut in iron homeostasis: role of HIF-2 under normal and pathological conditions. Blood 2013;122:885-92.
  • Malhotra J, Garg R, Malhotra N, Agrawal P. Oral Liposomal Iron: A Treatment Proposal for Anemia. World J Anemia 2017;1(4):1-6.
  • Li N, Zhao G, Wu W, Zhang M, Liu W, Chen Q, Wang X. The Efficacy and Safety of Vitamin C for Iron Supplementation in Adult Patients With Iron Deficiency Anemia: A Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2023644. doi: 10.1001/jamanetworkopen.2020.23644. PMID: 33136134; PMCID: PMC7607440.
  • Kaundal, R., Bhatia, P., Jain, A. et al. Randomized controlled trial of twice-daily versus alternate-day oral iron therapy in the treatment of iron-deficiency anemia. Ann Hematol 99, 57-63 (2020). https://doi.org/10.1007/s00277-019-03871-z
  • Hussain U, Zia K, Iqbal R, Saeed M, Ashraf N. Efficacy of a Novel Food Supplement (Ferfer®) Containing Microencapsulated Iron in Liposomal Form in Female Iron Deficiency Anemia. Cureus. 2019 May 7;11(5):e4603. doi: 10.7759/cureus.4603. PMID: 31309026; PMCID: PMC6609302.
  • 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. PMID: 34993390; PMCID: PMC8728001
  • Gómez-Ramírez S, Brilli E, Tarantino G, Muñoz M. Sucrosomial® Iron: A New Generation Iron for Improving Oral Supplementation. Pharmaceuticals (Basel). 2018 Oct 4;11(4):97. doi: 10.3390/ph11040097. PMID: 30287781; PMCID: PMC6316120.
  • Goddard AF, James MW, McIntyre AS, Scott BB; British Society of Gastroenterology. Guidelines for the management of iron deficiency anaemia. Gut. 2011 Oct;60(10):1309-16. doi: 10.1136/gut.2010.228874. Epub 2011 May 11. PMID: 21561874.
  • GBD 2021 Anaemia Collaborators. Prevalence, years lived with disability, and trends in anemia burden by severity and cause, 1990-2021: findings from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Sep;10(9):e713-e734. doi: 10.1016/S2352-3026(23)00160-6. Epub 2023 Jul 31. Erratum in: Lancet Haematol. 2023 Oct;10(10):e796. Erratum in: Lancet Haematol. 2024 Jan;11(1):e10. PMID: 37536353; PMCID: PMC10465717.
  • Eichner ER. Anemia in Athletes, News on Iron Therapy, and Community Care During Marathons. Curr Sports Med Rep. 2018 Jan;17(1):2-3. doi: 10.1249/JSR.0000000000000435. PMID: 29315098.
  • Ding B, Yi X, Li L, Yang H. Assessment of ferrous glycinate liposome absorption using in situ single-pass perfusion model. Int J Food Eng 2017 Aug;13(9):0358.
  • Cook JD, Reddy MB. Effect of ascorbic acid intake on nonheme-iron absorption from a complete diet. Am J Clin Nutr. 2001 Jan;73(1):93-8. doi: 10.1093/ajcn/73.1.93. PMID: 11124756.
  • Chaparro CM, Suchdev PS. Anemia epidemiology, pathophysiology, and etiology in low- and middle-income countries. Ann N Y Acad Sci. 2019 Aug;1450(1):15-31. doi: 10.1111/nyas.14092. Epub 2019 Apr 22. PMID: 31008520; PMCID: PMC6697587.
  • Carrero-Colomer, M. (2010) Tratamiento de la Anemia Ferropénica. Available at: https://www.elsevier.es:443/es-revista-offarm-4-pdf-X0212047X10540745 (Accessed: 29 January 2024). Cengiz A, Kahyaoglu T, Schröen K, Berton-Carabin C. Oxidative stability of emulsions fortified with iron: the role of liposomal phospholipids. J Sci Food Agric. 2019 Apr;99(6):2957-2965. doi: 10.1002/jsfa.9509. Epub 2019 Jan 17. PMID: 30471119; PMCID: PMC6590114.
  • Cappellini MD, Musallam KM, Taher AT. Iron deficiency anaemia revisited. J Intern Med. 2020 Feb;287(2):153-170. doi: 10.1111/joim.13004. Epub 2019 Nov 12. PMID: 31665543.
  • Brugnara C. A hematologic "gold standard" for iron-deficient states? Clin Chem. 2002 Jul;48(7):981-2. PMID: 12089163.
  • Bastida G, Herrera-de Guise C, Algaba A, Ber Nieto Y, Soares JM, Robles V, Bermejo F, Sáez-González E, Gomollón F, Nos P. Sucrosomial Iron Supplementation for the Treatment of Iron Deficiency Anemia in Inflammatory Bowel Disease Patients Refractory to Oral Iron Treatment. Nutrients. 2021 May 22;13(6):1770. doi: 10.3390/nu13061770. PMID: 34067320; PMCID: PMC8224651.
  • Baomiao D, Xiangzhou Y, Li L, Hualin Y. Evaluation of iron transport from ferrous glycinate liposomes using Caco-2 cell model. Afr Health Sci. 2017 Sep;17(3):933-941. doi: 10.4314/ahs.v17i3.37. PMID: 29085422; PMCID: PMC5656219.
  • Banerjee, A., Athalye, S., Shingade, P., Khargekar, V., Mahajan, N., Madkaikar, M., Khargekar, N. (2024). Efficacy of daily versus intermittent oral iron supplementation for prevention of anaemia among pregnant women: a systematic review and meta-analysis. eClinical Medicine, 74. https://doi.org/10.1016/j.eclinm.2024.102742

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Actual)

February 15, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-ECI-SF1-001-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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