| CTRI Number |
CTRI/2008/091/000057 [Registered on: 07/05/2008] |
| Last Modified On: |
14/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study whether zinc decreases the frequency of disease relapses in patients with frequently relapsing nephrotic syndrome |
|
Scientific Title of Study
|
Randomized, double blind, placebo controlled trial to examine the effectiveness of zinc supplementation in reducing relapse rates in patients with frequently relapsing nephrotic syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arvind Bagga |
| Designation |
|
| Affiliation |
|
| Address |
Professor, Department of Pediatrics,
#3053, All India Instiute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126593472 |
| Fax |
|
| Email |
arvindbagga@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Bagga |
| Designation |
|
| Affiliation |
|
| Address |
Professor, Department of Pediatrics,
#3053, All India Instiute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126593472 |
| Fax |
|
| Email |
arvindbagga@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Bagga |
| Designation |
|
| Affiliation |
|
| Address |
Professor, Department of Pediatrics,
#3053, All India Instiute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126593472 |
| Fax |
|
| Email |
arvindbagga@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
NIL |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 Arvind Bagga |
All India Institute of Medical Sciences |
Professor, Department of Pediatrics,All India Institute of Medical Sciences, Ansari Nagar-110029
New Delhi
DELHI |
01126593472
arvindbagga@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ehtics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Frequently relapsing nephrotic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo |
for 12 months |
| Intervention |
zinc sulfate |
20 mg elemental zinc for 12 months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
?Patients with steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding six months
?Prednisolone requirement at <1 mg/kg on alternate day to maintain remission
?No zinc supplements in the preceding 3 months
?Parents willing to give informed written consent. |
|
| ExclusionCriteria |
| Details |
?Grade IV protein energy malnutrition (Indian Academy of Pediatrics Classification)
?Body mass index >30, height less than -2 SD of that expected (NCHS)
?Patients with known secondary nephrotic syndrome (e.g., systemic lupus, infection with hepatitis B or C virus, amyloidosis)
?Receiving immunosuppressive treatment other than oral prednisolone and levamisole (i.e., pulse dexamethasone or methylprednisolone, cyclophosphamide, cyclosporine, tacrolimus, azathioprine or mycophenolate mofetil) or having received such treatment during the previous six months
?Known to have chronic infections e.g., tuberculosis, HIV, kala azar, hepatitis B or C or malignancy
?More than one episode of a life threatening complication in the past 6 months, e.g., meningitis, sepsis, peritonitis, thrombosis or hypovolemic shock
?Estimated glomerular filtration rate less than 60 ml/min/1.73 m2
?Residing more than 100 km from the Institute or unwilling to come for regular follow-up. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the rate of relapses in the two groups |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Rates of respiratory and diarrheal infections
•The proportion of patients with sustained remission
•The time to first relapse in the two groups
•Growth velocity (height gain over 12 months)
•Blood levels of zinc during the course of nephrotic syndrome
•Gene expressions for TH1 and TH2 cytokines in PBMCs
|
One year |
|
Target Sample Size
Modification(s)
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/08/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/08/2008 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study is a randomized, double blind, parallel group placebo controlled trial to examine the effectiveness of zinc supplementation at 20 mg daily for one year in reducing relapse rates in 57 patients with frequently relapsing nephrotic syndrome. the study will be conducted at one centre in India. the primary outcome measure will be rate of relapses at one year. the secondary outcome measures will include rates of respiratory and diarrheal infections at one year, proportion of patients with sustained remission at one year, the time to first relapse in the two groups, growth velocity (height gain over 12 months), blood levels of zinc at enrollment and at one year, and gene expressions for TH1 and TH2 cytokines in PBMCs at enrollment and at one year. |