A Study to Compare Liposomal Iron With Ferrous Ascorbate in the Treatment of Iron Deficiency Anemia in Children

Summary

This trial is designed to compare the efficacy of ferrous ascorbate versus liposomal iron for the treatment of nutritional iron deficiency anemia (IDA) amongst 6 to 59 months age children as determined by the increase in hemoglobin concentration and change in iron indices after 12 weeks of treatment. This study will be a randomized double-blinded single-center study done at the outpatient department of the Department of Pediatrics. All the children between 6 months to 59 months with nutritional IDA will be enrolled in the study. Written informed consent will be taken from the caregiver. At baseline detailed history will be taken and a complete physical examination will be done. Complete blood count (CBC), Peripheral smear, corrected reticulocyte count, Serum iron, Serum ferritin, and serum Total iron binding capacity(TIBC) will be done at baseline. Transferrin saturation will be calculated with the formula Serum Iron/ TIBC ×100. C Reactive Protein (CRP) and alpha1- acid glycoprotein (AGP) will be done to look for inflammation. Eligible subjects would be randomized in a 1:1 ratio by computerized software to receive either ferrous ascorbate or liposomal iron. Subjects in the ferrous ascorbate group would be given the drug at a dose of 3mg/kg/day OD of elemental iron. Subjects in the liposomal group would be given 1mg/kg/day OD of liposomal iron. Follow-up visits would be done at 4 and 12 weeks. Follow-up at 4 weeks is required to check the initial response to treatment and identify nonresponders and at 12 weeks is required to see the final response and thus decide upon continuation or discontinuation of treatment. In the follow-up visit at 4 and 12 weeks, CBC, Iron profile (Iron, Ferritin, and TIBC), CRP, and AGP will be done. Corrected Reticulocyte will be done at 4 weeks only. Any adverse effects of therapy will be noted. Adherence to therapy will be checked by measuring the volume of unused medicine in the bottle at each visit. All the statistically analyzed continuous data will be presented as mean ± standard deviation (SD). The categorical data will be reported as a percentage. Student's t-tests will be used to compare means. The χ2 test will be used to compare categorical outcomes, including the proportion of patients with dropouts, adverse effects, and adherence measures. The percentage volume of unused study medication returned at each visit will be compared using the Wilcoxon rank sign test. p\<0.05 will be considered statistically significant.

Timeline

Start

2023-08

Primary completion

2024-08

Completion

2025-02

Publications

• Background NFHS-5 fact sheets for key indicators based on final data (2019-21) http://rchiips.org/nfhs/NFHS-5_FCTS/India.pdf
• Background Sarna A, Porwal A, Ramesh S, Agrawal PK, Acharya R, Johnston R, Khan N, Sachdev HPS, Nair KM, Ramakrishnan L, Abraham R, Deb S, Khera A, Saxena R. Characterisation of the types of anaemia prevalent among children and adolescents aged 1-19 years in India: a population-based study. Lancet Child Adolesc Health. 2020 Jul;4(7):515-525. doi: 10.1016/S2352-4642(20)30094-8.
• Background Mantadakis E, Chatzimichael E, Zikidou P. Iron Deficiency Anemia in Children Residing in High and Low-Income Countries: Risk Factors, Prevention, Diagnosis and Therapy. Mediterr J Hematol Infect Dis. 2020 Jul 1;12(1):e2020041. doi: 10.4084/MJHID.2020.041. eCollection 2020.
• Background Orsango AZ, Habtu W, Lejisa T, Loha E, Lindtjorn B, Engebretsen IMS. Iron deficiency anemia among children aged 2-5 years in southern Ethiopia: a community-based cross-sectional study. PeerJ. 2021 Jun 28;9:e11649. doi: 10.7717/peerj.11649. eCollection 2021.
• Background Zeckanovic A, Kavcic M, Prelog T, Smid A, Jazbec J. Micronized, Microencapsulated Ferric Iron Supplementation in the Form of >Your< Iron Syrup Improves Hemoglobin and Ferritin Levels in Iron-Deficient Children: Double-Blind, Randomized Clinical Study of Efficacy and Safety. Nutrients. 2021 Mar 26;13(4):1087. doi: 10.3390/nu13041087.
• Background Moscheo C, Licciardello M, Samperi P, La Spina M, Di Cataldo A, Russo G. New Insights into Iron Deficiency Anemia in Children: A Practical Review. Metabolites. 2022 Mar 25;12(4):289. doi: 10.3390/metabo12040289.
• Background Guideline: Intermittent Iron Supplementation in Preschool and School-Age Children. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK179850/
• Background 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.
• Background Russo G, Guardabasso V, Romano F, Corti P, Samperi P, Condorelli A, Sainati L, Maruzzi M, Facchini E, Fasoli S, Giona F, Caselli D, Pizzato C, Marinoni M, Boscarol G, Bertoni E, Casciana ML, Tucci F, Capolsini I, Notarangelo LD, Giordano P, Ramenghi U, Colombatti R. Monitoring oral iron therapy in children with iron deficiency anemia: an observational, prospective, multicenter study of AIEOP patients (Associazione Italiana Emato-Oncologia Pediatrica). Ann Hematol. 2020 Mar;99(3):413-420. doi: 10.1007/s00277-020-03906-w. Epub 2020 Jan 21.
• Background Bhargava S, Meurer LN, Jamieson B, Hunter-Smith D. Clinical inquiries. What is appropriate management of iron deficiency for young children? J Fam Pract. 2006 Jul;55(7):629-30.
• Background Powers JM, Buchanan GR, Adix L, Zhang S, Gao A, McCavit TL. Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial. JAMA. 2017 Jun 13;317(22):2297-2304. doi: 10.1001/jama.2017.6846.
• Background Ozdemir N. Iron deficiency anemia from diagnosis to treatment in children. Turk Pediatri Ars. 2015 Mar 1;50(1):11-9. doi: 10.5152/tpa.2015.2337. eCollection 2015 Mar.
• Background WHO guideline on use of ferritin concentrations to assess iron status in individuals and populations [Internet]. Geneva: World Health Organization; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK569880/
• Background Nel E, Kruger HS, Baumgartner J, Faber M, Smuts CM. Differential ferritin interpretation methods that adjust for inflammation yield discrepant iron deficiency prevalence. Matern Child Nutr. 2015 Dec;11 Suppl 4(Suppl 4):221-8. doi: 10.1111/mcn.12175.
• Background Visciano B, Nazzaro P, Tarantino G, Taddei A, Del Rio A, Mozzillo GR, Riccio E, Capuano I, Pisani A. [Liposomial iron: a new proposal for the treatment of anaemia in chronic kidney disease]. G Ital Nefrol. 2013 Sep-Oct;30(5):gin/30.5.7. Italian.
• Background CDC Recommendations to prevent and Control Iron Deficiency in the United States 1998. https://www.cdc.gov/mmwr/preview/mmwrhtml/00051880.htm

Drugs

Indications