| CTRI Number |
CTRI/2024/07/069861 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effect of zinc as an add on therapy to prednisolone for producing early improvement in pediatric nephrotic syndrome patients |
|
Scientific Title of Study
|
To evaluate the efficacy and safety of zinc as an add on therapy to prednisolone for producing early remission of 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 Alok Kaushik |
| Designation |
Postgraduate student |
| Affiliation |
BPS Govt .Medical College for women,Khanpur Kalan,Sonipat |
| Address |
Department of Pharmacology,Bhagat Phool Singh Govt.MedicalCollege For Women,Khanpur Kalan,Sonipat ,Haryana
Sonipat HARYANA 131305 India |
| Phone |
9990353462 |
| Fax |
|
| Email |
233alok@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Garima Bhutani |
| Designation |
Proffesor |
| Affiliation |
BPS Govt Medical college For women |
| Address |
Department of Pharmacology,Bhagat Phool singh Govt.Medical college ,Khanpur Kalan ,Sonipat ,
Sonipat HARYANA 131305 India |
| Phone |
9992108132 |
| Fax |
|
| Email |
drgarimaahuja2013@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Alok Kaushik |
| Designation |
Post Graduation |
| Affiliation |
BPS Govt Medical College For women |
| Address |
Department of Pharmacology
BPS Govt Medical College ,Khanpur Kalan ,Sonipat
Sonipat HARYANA 131305 India |
| Phone |
9990353462 |
| Fax |
|
| Email |
233alok@gmail.com |
|
|
Source of Monetary or Material Support
|
| BPS Govt Medical College For women |
|
|
Primary Sponsor
|
| Name |
Bhagat Phool Singh Govt.Medical College For Women |
| Address |
Khanpur Kalan ,Sonipat ,Haryana
131305 |
| 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 Alok Kaushik |
BPS Govt. Medical College For Women |
Paediatrics IPD, BPSGMC(W), Khanpur Kalan, Sonipat, Haryana, 131305 Sonipat HARYANA |
9990353462
233alok@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 |
tablet prednisolone and syrup zinc |
tablet prednisolone 2mg/kg/day per oral(maximum 60mg) in single or divided doses for 6 weeks and syrup zinc 20 mg/kg per oral for 14 days or till the day of remission whichever is longer |
| Comparator Agent |
Tab prednisolone .
|
Tab prednisolone in a dose of2mg/kg/day per oral(maximum 60mg) in a single or divided doses for 6 weeks) followed by 1.5mg/kg per oral(maximum 40mg as a single morning dose on alternate days for next 6weeks |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Hospitalized children of age group 1-15 years presenting with 1st episode of nephrotic syndrome (as per criteria given in annexure 1)
2. Children whose parents/guardians are willing to give written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Children whose parents/guardians are not willing to give written informed consent to participate in the study.
2. Children with malabsorption
3. Children with malnutrition
4. Children with hepatic problems
5. History of chronic illness
6. Secondary causes of nephrotic syndrome.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight (in kgs), blood pressure, and fluid intake, and urinary protein, spot urinary albumin: creatinine ratio, 24 hr urine output and abdominal girth of the patients will be monitored at baseline and 24 hourly. |
baseline and 24 hourly till the day of remission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total serum protein, serum albumin, serum globulin, A:G ratio, serum cholesterol, serum creatinine and serum urea will be estimated at baseline and on the day of remission |
1st day and on the day of remission |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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="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 characterized by massive proteinuria, hypoalbuminemia, edema, hyperlipidemia, hypertension and rarely hematuria. It is an important chronic disease in children of age 2 to 7 year old. Management of nephrotic syndrome includes prednisolone 2mg/kg/day (maximum 60 mg) in single or divided doses for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg) as a single morning dose on alternate days for next 6 weeks. The present study is designed to evaluate the efficacy and safety of zinc as an add on therapy to prednisolone for producing early remission of pediatric nephrotic syndrome. 62 children fulfilling the inclusion criteria will be included in the study. The total duration of the study will be 12 months., To the check the efficacy of zinc which includes urinary assessment, spot urine protein creatinine ratio, BP, 24hr urine output, fluid intake, Abdominal girth will be assessed daily, however serum electrolyte, serum protein, lipid profile, serum creatinine, serum urea will be estimated at baseline and on the day of remission. Data will be entered into Microsoft excel sheet, an analytical software will be used for doing statistical analysis. Mean ± S.D will be calculated for quantitative data. Percentage and proportion will be calculated for qualitative data. Wills test will be used to check the normality of the data. Student t-test / Mann Whitney test will be used to find out the mean difference between two groups. Chi square test will be used to find out the association between categorical data using SPSS (statistical programme for social science) version-20 software. A P- value <0.05 will be considered as statistically significant. |