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AzTrials

Iron Deficiency AnemiaNCT07483645

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

An observational study of Iron Deficiency Anemia, run by Carnot Laboratories at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Observational, descriptive, prospective, longitudinal, multicenter, non-interventionist and multicentric study in Mexican subjects diagnosed with mild to moderate iron deficiency anemia (ADH). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Iron Deficiency Anemia
How many people
74 participants
Where
1 siteMexico
Study dates
6 May 2025to 30 Mar 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Mexican population in the usual clínica

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Winsett Rethman S.A. de C.V.

    Monterrey, Nuevo León, 64040

Other trials in Mexico

About this study

Official 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.

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.

Read the 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.

Keywords
Anemia, iron supplementation liposomal, hemoblogin, iron deficiency anemia
Medical subject headings
Anemia, Iron-Deficiency, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07483645
Study groupRoleWhat they receive
Grupo 1two sachets of LISEFEX® daily
Gurpo 2two packets of LISEFEX® on alternate days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin level

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start6 May 2025
  3. Primary completion15 Feb 2026
  4. Study completion30 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483645
Sponsor's protocol ID
PC-ECI-SF1-001-2024
Status last verified
Mar 2026
First submitted
10 Mar 2026
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guideline on haemoglobin cutoffs to define anaemia in individuals and populations [Internet]. Geneva: World Health Organization; 2024. Available from http://www.ncbi.nlm.nih.gov/books/NBK602198/

    PubMed 38530913

  • 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.

    PubMed 25053935

  • von Siebenthal HK, Gessler S, Vallelian F, Steinwendner J, Kuenzi UM, Moretti D, Zimmermann MB, Stoffel NU. Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. EClinicalMedicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286. eCollection 2023 Nov.

    PubMed 38021373

  • Ucan A, Kaya ZI, Yilmaz EO, Vasi I, Ozgeyik 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.

    PubMed 37505179

  • Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.

    PubMed 31413088

  • 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.

    PubMed 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.

    PubMed 38215133

  • Mejia-Rodriguez F, Mundo-Rosas V, Garcia-Guerra A, Mauricio-Lopez ER, Shamah-Levy T, Villalpando S, De la Cruz-Gongora V. Prevalencia de anemia en la poblacion mexicana: analisis de la Ensanut Continua 2022. Salud Publica Mex. 2023 Jun 14;65:s225-s230. doi: 10.21149/14771. Spanish.

    PubMed 38060969

  • Mastrogiannaki M, Matak P, Peyssonnaux C. The gut in iron homeostasis: role of HIF-2 under normal and pathological conditions. Blood. 2013 Aug 8;122(6):885-92. doi: 10.1182/blood-2012-11-427765. Epub 2013 May 15.

    PubMed 23678007

  • 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.

    PubMed 33136134

  • Kaundal R, Bhatia P, Jain A, Jain A, Nampoothiri RV, Mishra K, Jandial A, Goni D, Sandal R, Jindal N, Meshram A, Sharma R, Khaire N, Singh C, Khadwal A, Prakash G, Das R, Varma N, Varma S, Malhotra P, Lad DP. Randomized controlled trial of twice-daily versus alternate-day oral iron therapy in the treatment of iron-deficiency anemia. Ann Hematol. 2020 Jan;99(1):57-63. doi: 10.1007/s00277-019-03871-z. Epub 2019 Dec 6.

    PubMed 31811360

  • Hussain U, Zia K, Iqbal R, Saeed M, Ashraf N. Efficacy of a Novel Food Supplement (Ferfer(R)) Containing Microencapsulated Iron in Liposomal Form in Female Iron Deficiency Anemia. Cureus. 2019 May 7;11(5):e4603. doi: 10.7759/cureus.4603.

    PubMed 31309026

  • 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.

    PubMed 34993390

  • Gomez-Ramirez S, Brilli E, Tarantino G, Munoz M. Sucrosomial(R) Iron: A New Generation Iron for Improving Oral Supplementation. Pharmaceuticals (Basel). 2018 Oct 4;11(4):97. doi: 10.3390/ph11040097.

    PubMed 30287781

Questions about this trial

What is this clinical trial studying?

An observational study of Iron Deficiency Anemia, run by Carnot Laboratories at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07483645, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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