| CTRI Number |
CTRI/2025/07/090640 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of anaemia due to iron, vitamin B12 and folic acid deficiency in children suffering from nephrotic syndrome |
|
Scientific Title of Study
|
A study of nutritional anaemia in children with nephrotic syndrome and comparison of severity of anaemia with steroid responsiveness
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajanya Singh |
| Designation |
Postgraduate Year 1 |
| Affiliation |
ESIC Hospital, Basaidarapur |
| Address |
Paediatrics OPD, Second floor, OPD Building,
ESIC Hospital, Basaidarapur-110015
New Delhi
DELHI
110015
India |
| Phone |
8448630308 |
| Fax |
|
| Email |
rajanyasingh30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kumari Pratima |
| Designation |
Associate Professor, Department of Paediatrics |
| Affiliation |
ESIC Hospital, Basaidarapur |
| Address |
Room no.-258, Paediatrics OPD, Second floor, OPD Building,
ESIC Hospital, Basaidarapur-110015
New Delhi
DELHI
110015
India |
| Phone |
7042443562 |
| Fax |
|
| Email |
drkpratima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajanya Singh |
| Designation |
Postgraduate Year 1 |
| Affiliation |
ESIC Hospital, Basaidarapur |
| Address |
Paediatrics OPD, Second floor, OPD Building,
ESIC Hospital, Basaidarapur-110015
New Delhi
DELHI
110015
India |
| Phone |
8448630308 |
| Fax |
|
| Email |
rajanyasingh30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ESIC Hospital, Bsaidarapur, New Delhi |
| Address |
ESIC Hospital, Basaidarapur,
New Delhi-110015 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Rajanya Singh |
ESIC Hospital, Basaidarapur |
Room No.- 258, Paediatrics OPD, Second Floor, OPD Building, ESIC Hospital, Basaidarapur-110015
New Delhi- 110015
New Delhi
DELHI |
8448630308
rajanyasingh30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, ESIC-PGIMSR, Basaidarapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3 months–18 years, both newly diagnosed and those who are in follow-up at Paediatric Nephrology clinic. |
|
| ExclusionCriteria |
| Details |
Secondary Nephrotic Syndrome (e.g., Lupus nephritis) or other chronic illnesses (chronic kidney disease, chronic liver disease) or haematological disorders (e.g. thalassemia, sickle cell anaemia) or history of any ongoing febrile illness or history of daily haematinics/ vitamin B12/folate (oral/injectable) intake in the last 2 weeks or history of any blood transfusion in the last 3 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of nutritional anaemia (iron, vitamin B 12, folate deficiency) in children with nephrotic syndrome |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of the severity of anaemia in steroid responders and steroid non-responders in children with nephrotic syndrome |
18 months |
| Percentage of dimorphic anaemia in children with nephrotic syndrome |
18 months |
| Percentage of subclinical iron/ vitamin B12 /Folate deficiency in children with nephrotic syndrome |
18 months |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
18/07/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajanyasingh30@gmail.com].
- For how long will this data be available start date provided 31-07-2027 and end date provided 31-07-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a cross sectional observational study aimed to evaluate the percentage of anaemia due to iron, vitamin B12, and folate deficiencies in children with nephrotic syndrome. This will be conducted in ESIC Hospital, Basaidarapur in India. The Primary Outcome Measure is percentage of nutritional anaemia (iron, vitamin B12, folate deficiency) in children with nephrotic syndrome. The secondary outcome measures are comparison of the severity of anaemia in steroid responders and steroid non-responders in children with nephrotic syndrome, percentage of dimorphic anaemia in children with nephrotic syndrome and percentage of subclinical iron/ vitamin B12 /Folate deficiency in children with nephrotic syndrome. |