Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grupo 1 | two sachets of LISEFEX® daily | ||
| Gurpo 2 | two packets of LISEFEX® on alternate days. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin level | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Mexican population in the usual clÃnica
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iris E Torres Garcia, Medico | Principal Investigator | |
| Leonardo R Aguilar, Medico | Principal Investigator | |
| Willy Nava, Medico | Principal Investigator | |
| Edgar U Coronado, Medico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winsett Rethman S.A. de C.V. | Monterrey | Nuevo León | 64040 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38530913 | Result | 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/ | |
| 25053935 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
Not provided
Not provided
Not provided
Not provided
Not provided
| 38021373 | Result | 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. |
| 37505179 | Result | 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. |
| 31413088 | Result | 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. |
| 25395392 | Result | 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. |
| 38215133 | Result | 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. |
| 38060969 | Result | 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. |
| 23678007 | Result | 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. |
| Result | Malhotra J, Garg R, Malhotra N, Agrawal P. Oral Liposomal Iron: A Treatment Proposal for Anemia. World J Anemia 2017;1(4):1-6. |
| 33136134 | Result | 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. |
| 31811360 | Result | 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. |
| 31309026 | Result | 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. |
| 34993390 | Result | 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. |
| 30287781 | Result | 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. |
| 21561874 | Result | 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. |
| 37536353 | Result | GBD 2021 Anaemia Collaborators. Prevalence, years lived with disability, and trends in anaemia 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. |
| 29315098 | Result | 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. No abstract available. |
| Result | 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. |
| 11124756 | Result | 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. |
| 31008520 | Result | 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. |
| 30471119 | Result | Cengiz A, Kahyaoglu T, Schroen 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. |
| 31665543 | Result | 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. |
| 12089163 | Result | Brugnara C. A hematologic "gold standard" for iron-deficient states? Clin Chem. 2002 Jul;48(7):981-2. No abstract available. |
| 34067320 | Result | Bastida G, Herrera-de Guise C, Algaba A, Ber Nieto Y, Soares JM, Robles V, Bermejo F, Saez-Gonzalez E, Gomollon 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. |
| 29085422 | Result | 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. |
| 39114275 | Result | Banerjee A, Athalye S, Shingade P, Khargekar V, Mahajan N, Madkaikar M, Khargekar N. Efficacy of daily versus intermittent oral iron supplementation for prevention of anaemia among pregnant women: a systematic review and meta-analysis. EClinicalMedicine. 2024 Jul 17;74:102742. doi: 10.1016/j.eclinm.2024.102742. eCollection 2024 Aug. |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |