FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077786 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Association of biochemical markers as predictors of nephrotic syndrome in patients with nephrotic syndrome and healthy children- A case control Study. 
Scientific Title of Study   Association of biochemical markers as predictors of nephrotic syndrome in patients with nephrotic syndrome and healthy children A case control Study 
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 Nischita M Bellad 
Designation  MD Paediatrics  
Affiliation  Jawaharlal Nehru Medical College KLE University 
Address  Department of Paediatrics Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9538003672  
Fax    
Email  nischitabellad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. MAHANTESH.V.PATIL 
Designation  PROFESSOR 
Affiliation  Jawaharlal Nehru Medical College KLE University 
Address  Department of Paediatrics Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9483561674  
Fax    
Email  patilmv1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nischita M Bellad 
Designation  MD Paediatrics  
Affiliation  Jawaharlal Nehru Medical College KLE University 
Address  Department of Paediatrics Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9538003672  
Fax    
Email  nischitabellad@gmail.com  
 
Source of Monetary or Material Support  
Department of paediatric ,KLE Dr. Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru nagar, KLE hospital rooad , Belgaum, Karnatake, 590010  
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College 
Address  Department of Paediatric Jawaharlal Nehru Medical College Nehru nagar KLE Hospital Road, Belgaum, Karnataka, 590010 
Type of Sponsor  Private 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 
Dr Nischita M Bellad   KLE Dr Prabhakar Kore hospital belgaum  Department of Paediatrics Jawaharlal Nehru Medical College Nehru nagar KLE hospital road belgaum
Belgaum
KARNATAKA 
9538003673

nischitabellad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethical Commettee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N30-N39||Other diseases of the urinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Cases -Children between the age group 1-18 years with nephrotic syndrome.
Control- Children between the age group 1-18years who are all had negative clinical and laboratory indicator for nephrotic syndrome 
 
ExclusionCriteria 
Details  Children with steroid resistant nephrotic syndrome
Children with chronic kidney disease 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
find out the association of biochemical markers in predicting the development of NS by identifying the variations in the biochemical markers in patients with nephrotic syndrome and healthy children   the study will be conducted over a period of 1 year  
 
Secondary Outcome  
Outcome  TimePoints 
1. To identify the variations in biochemical markers namely albumin and/or non albumin proteins in patients with nephrotic syndrome and healthy children

To determine oncotic pressure in patients with nephrotic syndrome and healthy children based on the biochemical markers 
the study will be conducted over a period of 1 year  
 
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)   31/12/2024 
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="1"
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 - NO
Brief Summary  

Introduction: 

Nephrotic syndrome (NS) is the most common glomerulopathy in children between 2-18 years and  is a major contributing factor to the development of Chronic kidney disease(1,2,3).It is characterized by edema, heavy proteinuria (>1 g/m2 daily; >40 mg/m2/hr) and hypoalbuminemia (serum albumin <3 g/dL)(4,5) .The incidence ranges from 1.2 to 16.9 per 100,000 children annually(4,5).It is usually primary or idiopathic and may be associated with an underlying systemic illness in 5-10% of patients. There is a epidemiological evidence of higher incidence of nephrotic syndrome in children from South Asia (6).

Minimal change nephrotic syndrome (MCNS) accounts for 80% cases of nephrotic syndrome in children. Steroid sensitivity nephrotic syndrome is was usually MCNS (7). More than 90% of childhood nephrotic syndrome is primary (idiopathic).Other causes such as amyloidosis, vasculitis, systemic lupus erythematosus, post- infectious glomerulonephritis and hepatitis B nephopathy.GN and hepatitis nephropathy are infrequent(7). About 80% children with idiopathic nephrotic syndrome show remission of proteinuria following treatment with corticosteroids and are classified as ‘steroid sensitive’. Most patients have multiple relapses, placing them at risk for steroid toxicity, systemic infections and other complications. A small proportion of patients who are not steroid sensitive (steroid resistant) are also at risk for similar complications and renal insufficiency.(8,9).Frequent exacerbations  of  nephrotic syndrome in children can lead to end-stage renal disease, which usually necessitates transplantation of kidneys and/or weekly dialysis treatments  leading to outcomes that are associated with significant health, social, familial and financial burdens.(10).

 

Blood protein leakage especially albumin into the urine  is the hallmark of NS.Damage to the glomerular basement membrane meshwork is the commom change which leads to the leakage of proteins from blood (11) Plasma proteins larger than 70 Kilo Dalton (kd) are known to be blocked from crossing the glomerular basement membrane in healthy kidneys by a charge- and size-selective barrier (8-10.Low molecular weight proteins may also be  markedly increased in urine albumin in nephrotic syndrome(12,13,14). This may potentially result in cardiovascular complications including coagulopathy .Because of increased excretion of albumin, liver produces more protein vital to upkeep of oncotic pressure. Theses  proteins include alpha 1- macro globulin and beta-lipoproteins. Despite the different causes of nephrotic syndrome, research reporting on proteinuria and oncotic pressure has a biased focus on albumin(10). The   significance of theses additional protein in nephrotic syndrome has not yet been fully studied especially in Indian setting  which could potentially have implications for clinical management of nephrotic syndrome . Therefore the study is planned to find out the association of biochemical markers in predicting the development of NS by identifying the variations in the biochemical markers in patients with steroid sensitive nephrotic syndrome and healthy children.


Primary objective:

To find out the association of biochemical markers in predicting the development of NS by identifying the variations in the biochemical markers in patients with nephrotic syndrome and healthy children


Secondary Objectives:

1.      To identify the variations in biochemical markers namely albumin and/or non albumin proteins in patients with nephrotic syndrome and healthy children .

2.      To determine oncotic pressure in patients with nephrotic syndrome and healthy children based on the biochemical markers 


1.1   Source of Data: Children with nephrotic syndrome between the age 1-18 years coming to Paediatric nephrology OPD, Paediatric OPD and wards in

Dr.Prabhakar Kore Hospital and Medical Research Centre,Nehru Nagar, Belagavi during the study period.


   Study Design: A case -control study

 

Study Period: 1 year

 

  Sample size: 40 IN EACH GROUP 


SAMPLING METHOD:

After obtaining ethical clearance, a observational case-control study will be conducted in  children who fulfil the eligibility criteria. Informed consent will be obtained before enrolling in the study. The participants will be divided into 2 groups as Cases and controls.

At enrolment a routine medical examination will be conducted and the socio demographic, clinical and anthropometric parameters will be collected and recorded in a pretested questionnnaire by the investigator. .To determine the BMI formula weight/height squared will be used.

Sampling- A 6ml venous sample will be  taken from each participant while taking the necessary precautions to prevent hemolysis. At 7 am in the morning, 2ml of each blood sample will be taken in an EDTA tube and 4ml in a tube containing gel separator for processing. After the sample in gel separator coagulates. It is centrifuged at three thousand revolutions per minute for 10minutes to obtain the sera. The concentration of  urea, creatinine, calcium,albumin and non-albumin fractions (alpha 1, alpha 2, beta 1, beta 2, C-reactive protein, transferrin, M-component and gamma globulin) were measured using the sera.The various proteins are determined by capillary electrophoresis.

The oncotic pressure is calculated using the formula COPpl= alpha (2.8c+0.18c2+0.012c3) +beta (0.9c+0.12c2+0.004c3) where alpha=albumin,beta=globulin and c= total protein.(23)

 

 
Close