| CTRI Number |
CTRI/2024/07/071198 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Seroprevalence of Varicella antibodies in children and adolescents with Nephrotic Syndrome |
|
Scientific Title of Study
|
Seroprevalence of Varicella antibodies in children and adolescents with Nephrotic Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharathidasan B |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi -110001
New Delhi
DELHI
110001
India |
| Phone |
9910609047 |
| Fax |
|
| Email |
bharathidasan124@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Mukta Mantan |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi- 110001
New Delhi
DELHI
110001
India |
| Phone |
9968604315 |
| Fax |
|
| Email |
muktamantan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Mukta Mantan |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of paediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi -110001
New Delhi
DELHI
110001
India |
| Phone |
9968604315 |
| Fax |
|
| Email |
muktamantan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
Department of Paediatrics |
| Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrBharathidasan B |
Lok Nayak Hospital |
Department of Paediatrics, Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
DELHI |
9910609047
bharathidasan124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N04||Nephrotic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents with Nephrotic syndrome who are in remission |
|
| ExclusionCriteria |
| Details |
Patients with congenital nephrotic syndrome |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| IgG antibody titres against varicella in children and adolescents with steroid sensitive and steroid resistant nephrotic syndrome in disease remission |
Patients in disease remission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of antibody titres with disease type, duration, immunosuppressive treatment, past vaccination/varicella infection |
Patients in disease remission |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/08/2024 |
| 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 Applicable |
| 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
|
This study is an observational study to find out the seroprevalence of varicella antibodies in children and adolescents with nephrotic syndrome.The study will be conducted in 100 patients in the department of Paediatrics in Maulana Azad Medical college, New Delhi. The primary outcome will be to measure IgG antibody titres against varicella in children and adolescents with steroid sensitive and steroid resistant nephrotic syndrome in disease remission. The secondary outcome will be association of antibody titres with disease type,duration,immunosuppressive treatment, past vaccination/varicella infection |