| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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 |