| CTRI Number |
CTRI/2024/05/068170 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To check Hypothyroidism in nephrotic syndrome children |
|
Scientific Title of Study
|
Hypothyroidism in children with Nephrotic Syndrome-A one year cross sectional study |
| 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 Gokul Shreya |
| Designation |
MD Paediatrics |
| Affiliation |
Jawaharlal Nehru Medical College,KLE University |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Gangambika hostel, room no -6
Belgaum
KARNATAKA
590010
India |
| Phone |
7207703759 |
| Fax |
|
| Email |
shreya.sony03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DnyaneshDK |
| Designation |
Head of the department |
| Affiliation |
Jawaharlal Nehru Medical College,KLE University |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
KARNATAKA
590010
India |
| Phone |
9538123244 |
| Fax |
|
| Email |
drdnyaneshk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gokul Shreya |
| Designation |
MD Paediatrics |
| Affiliation |
Jawaharlal Nehru Medical College,KLE University |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Gangambika hostel, room no -6
Belgaum
KARNATAKA
590010
India |
| Phone |
7207703759 |
| Fax |
|
| Email |
shreya.sony03@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Belagavi |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College KLE University Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road, Belgaum, Karnataka, 590010 |
| Type of Sponsor |
Private 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 Gokul Shreya |
KLEs Dr Prabhakar Kore hospital, Belagavi |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum
KARNATAKA
Belgaum
KARNATAKA |
7207703759
shreya.sony03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N049||Nephrotic syndrome with unspecified morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1-18 years attending the paediatric OPD and admitted in ward at KLE Dr. Prabhakar Kore hospital with documented diagnosis of nephrotic syndrome |
|
| ExclusionCriteria |
| Details |
Children who had been prior documented with diagnosis of hypothyroidism before nephrotic syndrome diagnosis
-Children with history of neck or brain surgeries /radiations
-Children with endocrine disorders
-Children with any congenital renal abnormality or other renal disorders. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of hypothyroidism in children with nephrotic syndrome. |
The study will be conducted over a span of one year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of severity of hypothyroidism with the type of nephrotic syndrome. |
The study will be conducted over a span of one year. |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
10/06/2024 |
| 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="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
|
-In nephrotic syndrome children urinary albumin losses are not entirely compensated by increased hepatic synthesis , thus leading to hypoalbuminemia. Along with it, many other proteins, are also excreted in urine, some of them being hormones and hormone binding proteins. -The substantial urinary losses of thyroid hormones and thyroxin binding globulins have widely been found in patients with proteinuria. Total amount of hormone bound to thyroid binding globulin are diminished -In some patients with sustained nephrotic syndrome and prolonged proteinuria, continuous excretion of thyroid binding globulins can reduce levels of free thyroid hormones and increase TSH leading to hypothyroidism. -Furthermore, steroids which are the corner stone of treatment of nephrotic syndrome have also been reported to affect the release of TSH by the pituitary gland and can thus contribute to the development of hypothyroidism. |