| CTRI Number |
CTRI/2021/06/034046 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Endogenous steroid suppression in children and adolescents with nephrotic syndrome treated with steroids |
|
Scientific Title of Study
|
ADRENOCORTICAL SUPPRESSION IN CHILDREN AND ADOLESCENTS WITH NEPHROTIC SYNDROME TREATED WITH CORTICOSTEROIDS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganeshkrishna M |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Ward 13-B,
Department of Paediatrics,
Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi.
Ward 13-B,
Department of Paediatrics,
Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
8012435703 |
| Fax |
|
| Email |
ganeshmkrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMukta Mantan |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Ward 13-B,
Department of Paediatrics,
Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi.
Ward 13-B,
Department of Paediatrics,
Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9968604313 |
| Fax |
|
| Email |
muktamantan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMukta Mantan |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Ward 13-B,
Department of Paediatrics,
Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi.
Ward 13-B,
Department of Paediatrics,
Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9968604313 |
| Fax |
|
| Email |
muktamantan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi |
| 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 |
| Ganeshkrishna M |
Department of paediatrics,Lok Nayak Hospital. |
Department of paediatrics,
Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi.
New Delhi
DELHI |
8012435703
ganeshmkrishna@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: E273||Drug-induced adrenocortical insufficiency, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents with steroid sensitive or steroid resistant nephrotic syndrome in the age group of 1-18 years, presently in remission (partial or complete) and
1. Who received daily prednisolone in any dosage for ≥ 2 weeks in the last 1 year and they are now off steroids or
2. Are presently receiving low dose alternate day prednisolone therapy (<1 mg/kg/day) for atleast 8 weeks.
|
|
| ExclusionCriteria |
| Details |
1. Children with nephrotic syndrome who received daily corticosteroid therapy in any dosages in the last 8 weeks.
2. Children with nephrotic syndrome having serious bacterial infections like pneumonia, cellulitis, sepsis, meningitis etc or are hospitalised for any reason.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients having adrenocortical insufficiency defined as serum cortisol 18 ug/dL by a low dose ACTH stimulation test.
|
From OPD visit to individual patient samples will be analysed within five days.
Thesis will be done in a year for the suggested sample size. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Disease type, duration, cumulative steroid doses, correlation of steroid doses to baseline and stimulated serum cortisol values.
|
From OPD visit to individual patient samples will be analysed within five days.
Thesis will be done in a year for the suggested sample size. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/06/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
ADRENOCORTICAL SUPPRESSION IN CHILDREN AND ADOLESCENTS WITH NEPHROTIC SYNDROME TREATED WITH CORTICOSTEROIDS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To find out proportion of patients with nephrotic syndrome who are treated with steroids having endogenous steroid Suppression, using low dose ACTH. |