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CTRI Number  CTRI/2026/02/102665 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 01/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “A study comparing two iron supplements to improve hemoglobin levels in children with anemia” 
Scientific Title of Study   A Study to compare the efficacy of conventional iron and Liposomal iron in treatment of iron defieciency anemia 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Isha upadhyay  
Designation  Junior Resident  
Affiliation   
Address  8,janakpuri mala road
Department of pediatrics,hind institute of medical sciences,safedabad, barabanki
Kota
RAJASTHAN
324002
India 
Phone  09414782255  
Fax    
Email  ishaupadhyay07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Utkarsh bansal  
Designation  Head of Department  
Affiliation  Hind Institute of medical sciences  
Address  Department of pediatrics,Hind institute of medical sciences,safedabad,barabanki

Barabanki
UTTAR PRADESH
225001
India 
Phone  7985244354  
Fax    
Email  Utkarsh1003@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Isha upadhyay  
Designation  Junior Resident  
Affiliation  Hind Institute of Medical sciences 
Address  Department of pediatrics,Hind institute of medical sciences,safedabad,barabanki

Barabanki
UTTAR PRADESH
225001
India 
Phone  9414782255  
Fax    
Email  ishaupadhyay07@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Isha upadhyay  
Address  Department of Pediatrics,Hind Institute of Medical Sciences, safedabad, barabanki ,lucknow,uttarpradesh,India Pincode -225001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Isha upadhyay  Hind institute of Medical sciences  1st floor ,Department of pediatrics
Lucknow
UTTAR PRADESH 
09414782255

ishaupadhyay07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E611||Iron deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional iron   3mg/kg/day OD,oral for 12 weeks 
Intervention  Liposomal iron   1mg/kg/day OD,oral for 12 weeks 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1-Children aged 6 months to 18 years.
2-Children attending OPD or IPD of the Department of Pediatrics.
3-Diagnosed cases of nutritional iron deficiency anemia.
4-Diagnosis confirmed by hematological parameters (low hemoglobin with supportive iron indices).
5-Children whose parents/guardians give written informed consent.
6-Children who are willing and eligible for follow-up during the study period. 
 
ExclusionCriteria 
Details  1-Children with other causes of anemia, such as:
Hemolytic anemia,Bone marrow failure syndromes
2-Children with history of acute blood loss.
3-Children who have received oral iron therapy or blood transfusion in the past 3 months.
4-Children with diseases affecting iron absorption such as:Celiac disease,Inflammatory bowel disease,History of bowel surgery,Chronic gastrointestinal infections
5-Children with serious chronic medical illnesses, including:Chronic kidney disease (CKD),Congenital heart disease (CHD),Chronic lung disease (CLD)
6-Children with malignancy of any type.
7-Children with known hypersensitivity or allergy to iron preparations.
8-Infants below 6 months of age. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is to look for improvement in the anemia status and compare it in both the groups.  At baseline , 1 month , 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Nil   
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="3" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Introduction
Iron deficiency anemia (IDA) is the most common nutritional anemia worldwide and remains a major public health concern among children and adolescents, particularly in developing countries like India. Factors such as rapid growth, inadequate dietary intake, recurrent infections, parasitic infestations, and low socioeconomic status contribute significantly to its high prevalence. IDA during childhood is associated with impaired cognitive development, reduced immunity, poor growth, and decreased scholastic performance, making early diagnosis and effective treatment essential.
Need for the Study
Oral iron supplementation is the cornerstone of treatment for nutritional IDA. Conventional iron preparations such as ferrous salts are commonly used but are often associated with gastrointestinal side effects, poor palatability, and reduced compliance, leading to inadequate therapeutic response. Liposomal iron, a newer formulation, offers improved bioavailability and better gastrointestinal tolerability due to its unique absorption through intestinal M cells and lymphatic transport. However, evidence comparing its efficacy and safety with conventional iron in the pediatric population is limited, particularly in the Indian setting.
Knowledge Gaps
There is a paucity of well-designed prospective studies comparing liposomal iron with conventional iron in children. Data regarding hematological response, adverse effect profile, and treatment adherence with liposomal iron in pediatric iron deficiency anemia remain insufficient, necessitating further research.
Aim and Objectives
The aim of this study is to compare the efficacy of conventional iron and liposomal iron in the treatment of iron deficiency anemia in children.
The primary objective is to compare the rise in hemoglobin concentration after 12 weeks of therapy between the two groups.
The secondary objectives include comparison of changes in MCV, corrected reticulocyte count, serum iron, serum ferritin, TIBC, transferrin saturation, adverse drug reactions, and treatment adherence.
Materials and Methods
This is a prospective comparative study conducted in the Department of Pediatrics, at a medical College in Barabanki district of central Uttar Pardesh. Children aged 6 months to 18 years diagnosed with nutritional iron deficiency anemia will be enrolled. A total of 80 participants will then randomized into two groups: one receiving conventional iron (ferrous ascorbate) and the other receiving liposomal iron. Patients are followed for 12 weeks, and clinical response, hematological parameters, adverse effects, and compliance are assessed and compared between the two groups.
Review of Literature
Previous studies have demonstrated that conventional iron preparations effectively increase hemoglobin levels but are frequently associated with gastrointestinal side effects. Emerging evidence suggests that liposomal iron provides comparable efficacy with improved tolerability and better patient compliance. However, limited pediatric data highlight the need for further comparative studies to establish its role in routine clinical practice
References
1 World Health Organization Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity Vitamin and Mineral Nutrition Information System Geneva WHO 2011
2 Sarna A Porwal A Ramesh S et al Characterisation of the types of anaemia prevalent among children and adolescents aged 1 to 19 years in India a population based study Lancet Child and Adolescent Health 2020 4 7 515 to 525
3 Mantadakis E Chatzimichael E Zikidou P Iron deficiency anemia in children residing in high and low income countries risk factors prevention diagnosis and therapy Mediterranean Journal of Hematology and Infectious Diseases 2020 12 1
4 Patil P Geevarghese P Khaire P et al Comparison of therapeutic efficacy of ferrous ascorbate and iron polymaltose complex in iron deficiency anemia in children A randomized controlled trial Indian Journal of Pediatrics 2019 86 1112 to 1117
5 Russo G Guardabasso V Romano F et al Monitoring oral iron therapy in children with iron deficiency anemia An observational prospective multicenter study Annals of Hematology 2020 99 3 413 to 420
6 Pisani A Riccio E Sabbatini M et al Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anemia A randomized trial Nephrology Dialysis Transplantation 2015 30 4 645 to 652
 
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