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CTRI Number  CTRI/2026/03/106324 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To assess iron deficiency levels in blood using laboratory parameters in children aged 1 month to 18 years with congenital heart disease 
Scientific Title of Study   Evaluation of iron deficiency anemia in patient with congenital heart disease 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Bandaru Pravallika 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Pediatrics, Jawaharlal Nehru Medical College, Sawangi, Wardha, 442107

Wardha
MAHARASHTRA
442001
India 
Phone  9398088045  
Fax    
Email  pravallikabandaru939@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shantanu Gomase 
Designation  Associate Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Pediatrics, Jawaharlal Nehru Medical College, Sawangi, Wardha, 442107

Wardha
MAHARASHTRA
442107
India 
Phone  9604568653  
Fax    
Email  Drgomase@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bandaru Pravallika 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Pediatrics, Jawaharlal Nehru Medical College, Sawangi, Wardha, 442107

Wardha
MAHARASHTRA
442107
India 
Phone  9398088045  
Fax    
Email  pravallikabandaru939@gmail.com  
 
Source of Monetary or Material Support  
DMIHER, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharastra, India, 442107 
 
Primary Sponsor  
Name  Bandaru Pravallika 
Address  Department of Pediatrics, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharastra, india, 442107 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
DMIHER  DMIHER, Jawaharlal Nehru Medical College, Sawangi, Wardha 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bandaru Pravallika  Acharya Vinobabhave Rural Hospital  Department of Pediatrics, Jawaharlal Nehru Medical College, Sawangi, Wardha
Wardha
MAHARASHTRA 		 9398088045

pravallikabandaru939@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, DMIHER (DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q249||Congenital malformation of heart,unspecified, (2) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 1 months to 18 years with a confirmed diagnosis of congenital heart
disease.

Children whose parents or guardians provide informed consent.  
 
ExclusionCriteria 
Details  Children with known hematological disorders other than iron deficiency anemia.

Children with chronic illnesses affecting nutritional status (e.g., tuberculosis, HIV).

Children who have undergone corrective cardiac surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of iron deficiency anemia and its association with CHD and growth parameters  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the association between iron deficiency anemia in children with CHD.
 		 2 years 
To assess the correlation between iron deficiency anemia and its associations with
anthropometric measurements.

 		 2 years 
To determine the diagnostic utility of serum ferritin, transferrin saturation, and soluble transferrin receptor (sTfR) in this subset.
 		 2 years 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   24/03/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pravallikabandaru939@gmail.com].

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 11-09-2029?
    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 proposal focuses on evaluating iron deficiency anemia (IDA) in children with congenital heart disease (CHD), a group particularly vulnerable due to chronic hypoxia, increased iron demand, and nutritional challenges. The study aims to determine the prevalence of IDA, its association with growth parameters, and the diagnostic utility of markers such as serum ferritin, transferrin saturation, and soluble transferrin receptor (sTfR).

The research will be conducted as a hospital-based cross-sectional observational study over two years, enrolling children aged 1 month to 18 years with confirmed CHD. Anthropometric measurements and laboratory investigations (hemoglobin, ferritin, iron studies) will be performed. A sample size of 110 participants has been calculated. Statistical analysis will include t-tests, Chi-square, correlation, and regression to identify predictors.

The proposal highlights the clinical and public health importance of early detection and management of IDA in CHD patients, noting its impact on exercise capacity, surgical outcomes, and developmental progress. By integrating iron profiling into routine care, the study seeks to improve long-term outcomes and guide evidence-based interventions in resource-limited settings.

 
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