| CTRI Number |
CTRI/2025/09/094614 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Zinc supplementation in children with Nephrotic Syndrome to see if it helps them stay well and avoid relapses. |
|
Scientific Title of Study
|
Effect of Zinc Supplementation on Sustained Remission in Children with 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 |
Varistha Shaw |
| Designation |
Postgraduate Resident |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Department of Paediatrics, 3rd Floor, AIIMS Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh 273008.
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9007752548 |
| Fax |
|
| Email |
varisthashaw123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahima Mittal |
| Designation |
Professor and Head of the Department, Department of Paediatrics, AIIMS Gorakhpur |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Department of Paediatrics, 3rd Floor, AIIMS Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh 273008.
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9415051567 |
| Fax |
|
| Email |
drmahimamittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varistha Shaw |
| Designation |
Postgraduate Resident |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Department of Paediatrics, 3rd Floor, AIIMS Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh 273008.
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9007752548 |
| Fax |
|
| Email |
varisthashaw123@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh- 273008 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Gorakhpur. |
| Address |
AIIMS Gorakhpur, Kunraghat, Gorakhpur, Pincode- 273008 |
| 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 |
| Varistha Shaw |
AIIMS Gorakhpur |
AIIMS Gorakhpur, Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH |
9007752548
varisthashaw123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Gorakhpur |
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 |
| Comparator Agent |
Standard therapy alone |
Prednisolone as per protocol only. |
| Intervention |
Zinc plus standard therapy |
Zinc will be given 10 mg per oral OD for 3 months in addition to standard therapy. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
First episode or relapse of nephrotic syndrome |
|
| ExclusionCriteria |
| Details |
1. Congenital Nephrotic Syndrome.
2. Steroid Dependent Nephrotic Syndrome or Frequently Relapsing Nephrotic Syndrome currently on low-dose steroids.
3. Steroid Resistant Nephrotic Syndrome.
4. Secondary Nephrotic Syndrome (e.g., diabetes mellitus, systemic lupus erythematosus, infections including hepatitis B/ hepatitis C/ HIV/ tuberculosis, malignancy, drug-induced).
5. Recent (within past 6 months) or concurrent use of other immunosuppressants (levamisole, cyclophosphamide, calcineurin inhibitors, rituximab).
6. Chronic systemic illness (e.g., chronic kidney disease).
7. Hypersensitivity to zinc supplementation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sustained remission (i.e., no relapse after initial remission) |
at the end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of relapses over the study period. |
noted on follow-ups during the study period of 6 months. |
| Time to first relapse after starting supplementation. |
noted on follow-ups during the study period of 6 months. |
| Number of infection episodes during follow-up. |
noted on follow-ups during the study period of 6 months. |
| Adverse effects of zinc like metallic taste, GI upset and others. |
noted on follow-ups during the study period of 6 months. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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)
|
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
|
Nephrotic Syndrome is a common pediatric glomerular disease. While most children respond to corticosteroids, many experience relapses, often triggered by infections. Zinc, an essential micronutrient for immune function, has been linked to reduced infection risk and improved T-cell responses. Trials suggest zinc supplementation may lower relapse frequency in children with Nephrotic Syndrome, but variations in study design and outcomes limit firm conclusions. Most studies also evaluate relapses only during supplementation. This study aims to address that gap by assessing whether standardized low-dose zinc supplementation over an intermediate duration with structured follow-up promotes sustained remission. |