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

NCT05957328 | Unknown Phase 3 DMC

• 1 other identifier: AIIMS/RBL/IRC/69/2022
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutritional Anemia

Keywords

iron deficiency anemia; liposomal iron; under 5 children

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin concentration

  Change from baseline hemoglobin concentration at 4 and 12 weeks post initiation of therapy

  0,4 and 12 weeks

Secondary Outcomes (8)

• Change in serum ferritin

  0,4 and 12 weeks

• Change in Mean corpuscular volume (MCV)

  0,4 and 12 weeks

• Change in serum iron

  0,4 and 12 weeks

• Change in total iron binding capacity (TIBC)

  0,4 and 12 weeks

• Change in transferrin saturation

  0,4 and 12 weeks

Study Arms (2)

liposomal iron group

ACTIVE COMPARATOR

The group would be given liposomal iron syrup at a dose of 1mg per kg per day once a day for 3 months

Drug: Ferric Pyrophosphate Liposomal

ferrous ascorbate group

ACTIVE COMPARATOR

The group would be given ferrous ascorbate syrup at a dose of 3mg per kg per day once a day for 3 months

Drug: ferrous ascorbate

Interventions

Ferric Pyrophosphate Liposomal DRUG

Liposomal iron, a form of ferric pyrophosphate is transported within a phospholipid membrane, absorbed by the intestinal M cells, reaches to the liver directly through lymphatics and finally released. Due to this mechanism, liposomal iron has been reported to have better bioavailability than traditional iron preparations thus requiring lesser dose and producing fewer adverse effects The group would be given liposomal iron syrup at a dose of 1mg per kg per day once a day for 3 months

Also known as: liposomal iron

liposomal iron group

ferrous ascorbate DRUG

one of the most commonly used forms of iron syrup in children. The group would be given ferrous ascorbate syrup at a dose of 3mg per kg per day once a day for 3 months

Also known as: Feronia XT,

ferrous ascorbate group

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children in the age group 6 to 59 months with Nutritional Iron Deficiency Anaemia as confirmed by hematological parameters

You may not qualify if:

• Subjects with other causes of anemia(hemolytic anemia, bone marrow failure) as evidenced by clinical symptoms and signs and or laboratory values
• Subjects with ongoing blood loss
• Subjects who have received any iron therapy or blood transfusion in the past 3 months
• Subjects with disease interfering with iron absorption e.g. Inflammatory bowel disease, celiac disease, bowel surgery, chronic gastrointestinal infection
• Subjects with serious chronic medical conditions like chronic kidney disease, congenital heart disease, and chronic lung disease.
• Subjects with prior history of allergy to iron preparations

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

Raebareli, Uttar Pradesh, 229405, India

Location

Related Publications (16)

• 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.

  PMID: 32562633 BACKGROUND

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  PMID: 34249504 BACKGROUND

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  PMID: 33810451 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.

  PMID: 35448476 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/

  PMID: 24479203 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.

  PMID: 25395392 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.

  PMID: 31965272 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.

  PMID: 16822452 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.

  PMID: 28609534 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.

  PMID: 26078692 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/

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  PMID: 25721990 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.

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MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Namita Mishra, MDPediatrics

  AIIMS Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Namita Mishra, MDPediatrics

CONTACT

9450789623; namitam23@gmail.com

Amit Shukla, MDPediatrics

CONTACT

7376814209; amitshuklabrd05@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: July 24, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Information will be provided 6 months after data collection is complete and will be available for next 6 months
• Access Criteria: Journal with whom research will be published can access the data

Locations

IN (1)