CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/04/084514 [Registered on: 09/04/2025] Trial Registered Prospectively

Last Modified On:

02/09/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of Oral Liposomal ferric pyrophosphate vs Oral ferrous sulfate in children aged 2-14years with Iron deficiency anemia

Scientific Title of Study

Comparison of Oral Liposomal Ferric pyrophosphate vs Oral Ferrous sulfate in children aged 2-14 years with Iron Deficiency Anemia: An Open Label Randomized Control Trial (LIFEPYSUL trial : LIposomal FErric PYrophosphate vs Ferrous SUlfate)

Trial Acronym

LIFEPYSUL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Pallavi Samariya
Designation	Assistant Professor
Affiliation	All India Institute of Medical Sciences, Mangalagiri, Guntur, AP
Address	Department of Pediatrics All India Institute of Medical Sciences, Mangalagiri, Guntur, AP Guntur ANDHRA PRADESH 522503 India
Phone	8424064142
Fax
Email	pallavisamariya04@gmail.com

Details of Contact Person
Scientific Query

Name	Pallavi Samariya
Designation	Assistant Professor
Affiliation	All India Institute of Medical Sciences, Mangalagiri, Guntur, AP
Address	Department of Pediatrics All India Institute of Medical Sciences, Mangalagiri, Guntur, AP ANDHRA PRADESH 522503 India
Phone	8424064142
Fax
Email	pallavisamariya04@gmail.com

Details of Contact Person
Public Query

Name	Arun Babu T
Designation	Professor and Head of the Department
Affiliation	All India Institute of Medical Sciences, Mangalagiri, Guntur, AP
Address	Department of Pediatrics All India Institute of Medical Sciences, Mangalagiri, Guntur, AP Guntur ANDHRA PRADESH 522503 India
Phone	9944701700
Fax
Email	babuarun@yahoo.com

Source of Monetary or Material Support

All India Institute of Medical Sciences, Mangalagiri, AP Intramural Project

Primary Sponsor

Name	All India Institute of Medical Sciences, Mangalagiri
Address	All India Institute of Medical Sciences, Mangalagiri, Guntur, AP-522503
Type of Sponsor	Government medical college

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
DrPallavi Samariya	All India Institute of Medical Sciences, Mangalagiri	Room no 321, Department of Pediatrics, All India Institute of Medical Sciences, Mangalagiri, Guntur, AP -522503 Guntur ANDHRA PRADESH	8424064142 pallavisamariya04@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 2
Name of Committee	Approval Status
AIIMS Mangalagiri Ethics Committee	Approved
AIIMS Mangalagiri Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy children aged 2-14 years

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Ferrous sulfate	Group B will receive Ferrous sulphate Dose: 5mg/kg/day Route of Administration : Per oral Duration : 90 days
Intervention	Liposomal Ferric Pyrophosphate	Group A will receive oral liposomal ferric pyrophosphate Dose: 1 mg/kg/day Route of Administration : Per oral Duration : 90 days

Inclusion Criteria

Age From	2.00 Year(s)
Age To	14.00 Year(s)
Gender	Both
Details	Children aged 2-14 years with Iron deficiency anemia defined as per World Health Organization guidelines

ExclusionCriteria

Details

1.Children with anemia due to other etiological causes.

2.Received iron therapy in the past 3 months.

3.Children with Severe Iron Deficiency Anemia as per WHO definition will be excluded from the study

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To assess the increase in hemoglobin level in children with iron deficiency anemia treated with oral liposomal ferric pyrophosphate therapy in comparison to oral ferrous sulfate therapy.	12weeks (90 days) after initiation of therapy in both the groups

Secondary Outcome

Outcome	TimePoints
To assess the proportion of patients with iron deficiency anemia who developed side effects on treatment with oral liposomal ferric pyrophosphate compared to oral ferrous sulfate therapy	12 weeks (90 days) after the initiation of therapy in both the groups

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
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

Phase 3/ Phase 4

Date of First Enrollment (India)

21/04/2025

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="8"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

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

Iron deficiency anemia is the most common nutritional hematological disorder in children. Traditional oral Iron therapy in children has been poorly tolerated due to a multitude of gastrointestinal side effects. Hence various iron formulations have been developed to overcome this shortfall but the efficacy and side effect profile of the numerous iron formulations are almost similar. Liposomal ferric pyrophosphate is a new drug that has been introduced with the utilization of advanced pharmacodynamics of the drug delivery system. The usage of this drug in the pediatric population has been underexplored despite preliminary data on better efficacy and lesser side effects.

The objective of this study is to compare the efficacy and adverse effect profile of oral liposomal ferric pyrophosphate with oral ferrous sulfate. The outcome of the study would be to assess the rise of hemoglobin levels in children after the administration of both drugs.

All children in the age group 2-14 years with iron deficiency anemia attending the department of pediatrics fulfilling the eligibility criteria will be included in the study after written consent.

Detailed clinical assessment as well as laboratory evaluation to assess anemia will be carried out. Assessment of anemia will be as per the World Health Organisation(WHO) guidelines. Children with other etiological causes of anemia will be excluded.

Children will be divided into Group A and Group B by using a block randomization method by a person not involved in data collection and analysis. Allocation concealment will be ensured while assigning treatment to both groups. It will be an open-label trial due to the variation in the color and consistency of the iron formulations being used in the study.

Group A will receive oral liposomal ferric pyrophosphate at a dose of 1 mg/kg/day and Group B will receive oral ferrous sulfate at 5mg/kg/day for 90 days. To ensure compliance and maintain a record of the side effects of the drugs being taken by participants, all the caregivers/participants will be advised to maintain a diary.

Repeat laboratory assessment will be done after 90 days of treatment by evaluating the hemoglobin levels and serum iron profile.

Data collected will be analyzed. The efficacy of the drugs will be assessed in terms of the rise in hemoglobin levels noted in children on oral liposomal ferric pyrophosphate with respect to oral ferrous sulfate therapy. The adverse effects of both drugs will also be compared as a part of the secondary objective.