| CTRI Number |
CTRI/2025/10/095938 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of zinc supplementation in pediatric nephrotic syndrome |
|
Scientific Title of Study
|
Role of zinc supplementation in reducing relapse rate in pediatric nephrotic syndrome: a randomized- controlled trial |
| 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 Prashant Kumar Verma |
| Designation |
Additional Prof |
| Affiliation |
Department of pediatrics, AIIMS Rishikesh |
| Address |
department of pediatrics
AIIMS Rishikesh
department of pediatrics
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9412592332 |
| Fax |
|
| Email |
abhimanyumehla4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar Verma |
| Designation |
Additional Prof |
| Affiliation |
AIIMS RIshikesh |
| Address |
department of pediatrics
AIIMS Rishikesh
department of pediatrics
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9412592332 |
| Fax |
|
| Email |
2004pkv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Kumar Verma |
| Designation |
Additional Prof |
| Affiliation |
AIIMS RIshikesh |
| Address |
department of pediatrics
AIIMS Rishikesh
department of pediatrics
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9412592332 |
| Fax |
|
| Email |
2004pkv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Non-funded thesis proposal |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh Virbhadra Road Rishikesh Uttarakhand 249203 India |
| 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 |
| Dr Prashant Kumar Verma |
AIIMS Rishikesh |
Pediatric ward
AIIMSR
Dehradun
UTTARANCHAL |
9412592332
2004pkv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
RDA doses of Zinc |
Zinc RDA as per WHO guidelines in addition to standard care |
| Comparator Agent |
Standard care |
Standard care |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed or any follow up case of steroid-sensitive nephrotic syndrome
Informed consent from parents or legal guardians
|
|
| ExclusionCriteria |
| Details |
1.Steroid-resistant nephrotic syndrome
2.Congenital or secondary nephrotic syndrome
3.Severe or chronic infections (e.g., tuberculosis, HIV, hepatitis)
4.Chronic systemic illnesses or known zinc metabolism disorders
5.Ongoing zinc supplementation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| frequency of relapse rates |
six months from study enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of zinc supplementation on infection-related relapse rates. To assess the effect of zinc on the time to first relapse after remission.
To evaluate the number of infection episodes during the study period. |
6 months duration |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
15/11/2025 |
| 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="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
|
Immunity has major role in
the occurrence of relapse in nephrotic syndrome. Zinc plays a crucial role in
rectifying immune dysfunction. Thus the
study can help reducing the relapse rate and decreasing the disease burden. Recommended daily
dietary Allowance For zinc will be administrated as per WHO guidelines.
|