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CTRI Number  CTRI/2025/03/082342 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two oral iron formulation in preterm infants 
Scientific Title of Study   Comparative efficacy of oral liposomal iron vs oral colloidal iron (standard care) in improving iron status in preterm infants of gestational age 30 to 34 weeks - A Double blind randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Nivetha 
Designation  Postgraduate resident 
Affiliation  Madras medical college  
Address  Institute of child health and hospital for children Department of paediatrics Room No: E block 3 floor Tamil Salai road Egmore Chennai -60008

Chennai
TAMIL NADU
600008
India 
Phone  7550144237  
Fax    
Email  nivethasmbbs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mangala bharathi 
Designation  Head of the department Neonatologist  
Affiliation  Madras medical college  
Address  Institute of child health and hospital Department of Newborn Room no 1 Chennai

Chennai
TAMIL NADU
600008
India 
Phone  9840786836  
Fax    
Email  drmangalabharathi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nivas 
Designation  Assistant professor  
Affiliation  Madras medical college  
Address  Institute of child health and hospital Departments of paediatrics Egmore Chennai

Chennai
TAMIL NADU
600008
India 
Phone  9710606400  
Fax    
Email  ahtevin1211@gmail.com  
 
Source of Monetary or Material Support  
Institute of obstetrics and gynaecology Department of newborn care Egmore chennai 
Nivetha S Institute of child health and hospital Egmore Chennai 600008 
 
Primary Sponsor
Modification(s)  
Name  Self 
Address  Institute of child health and hospital for children Department of Paediatric Egmore chennai-600008 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
DrMangalabharathi  Department of Neonatology Institute of obstetrics and gynaecology Egmore 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr NIVETHA  Institute of obstetrics and gynaecology   Institute of obstetrics and gynaecology Egmore Department of newborn Egmore Chennai
Chennai
TAMIL NADU 		 7550144237

nivethasmbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Madras medical college   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liposomal iron at a dose of 3mg/kg/day Per oral Once daily for 2 months Oral colloidal iron at a dose of 3mg/kg/day per oral once daily for 2 months  Iron supplements started at dose of 3mg/kg/day once daily 2 weeks after birth and given till 1 year of life They are followed up after 4 weeks and 8 weeks after starting iron supplementation  
Intervention  Liposomal oral iron formulation   Liposoml iron at a dose of 3mg/kg/day per oral once daily for 2 months started after 2 weeks of birth.they are followed up after 4 weeks and 8 weeks after starting iron supplementation 
Comparator Agent  Oral colloidal iron  Oral colloidal iron at a dose of 3mg/kg/day per oral once daily for 2 months started after 2 weeks of birth.they are followed up after 4weeks and 8 weeks after starting iron therapy 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Month(s)
Gender  Both 
Details  Preterm infants of gestational age 30-34 weeks
On exclusive breast feeding
On full enteral nutrition  
 
ExclusionCriteria 
Details  Preterm who had
Blood transfusions
Congenital gastrointestinal malformations
Necrotising enterocolitis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess change in serum ferritin level  To assess change in serum ferritin level of baseline and at 4 weeks and 8 weeks after iron supplementation 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess increase in hemoglobin levels
2.Assess pattern of weight gain
3.To determine the gastrointestinal side effects oral iron therapy  		 2 months 
 
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   Phase 4 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 04-10-2024 and end date provided 04-10-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This studies done to compared the efficacy of two oral iron formulations in preterm infants of gestational age 30 to 34 weeks based on serum ferritin levels A double blind randomised controlled trial  
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