| CTRI Number |
CTRI/2024/04/066257 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Age and Gender Specific Chart for Indian Children to Assess Muscle Wasting Growth and Development |
|
Scientific Title of Study
|
Age and Gender Specific Sarcopenia Nomogram for Indian Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Mohamed Rela |
| Designation |
Chairman and Managing Director |
| Affiliation |
Rela Institute and Medical Centre |
| Address |
Room 106 First Floor
Institute and Liver Disease and Transplantation
Dr Rela Institute and Medical Centre
No 7 CLC Work Road
Chromepet
Chennai
TAMIL NADU
600044
India |
| Phone |
9729440890 |
| Fax |
|
| Email |
mohamed.rela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Rammohan |
| Designation |
Director of Academics , Consultant HPB and Liver Transplant Surgeon |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Room No 4066 Academics Block,
Dr. Rela Institute and Medical Centre
No 7 CLC Work Road
Chromepet
Chennai
TAMIL NADU
600044
India |
| Phone |
9884173583 |
| Fax |
|
| Email |
ashwinrammohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan Garg |
| Designation |
Fellow in HPB Sx and Liver Transplantation |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Room No 3010, Third Floor
Institute of Liver Disease and Transplantation
Dr. Rela Institute and Medical Centre
No 7 CLC Work Road
Chromepet
Chennai
TAMIL NADU
600044
India |
| Phone |
9729440890 |
| Fax |
|
| Email |
rajangarg1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prof. Mohamed Rela
Dr. Rela Institute and Medical Centre,
No 7, CLC Works Road
Chromepet
Chennai 600044 |
|
|
Primary Sponsor
|
| Name |
Prof Mohamed Rela |
| Address |
Dr. Rela Institute and Medical Centre
No 7 CLC Works Road
Chromepet
Chennai 600044 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajan Garg |
Dr Rela Institute and Medical Centre |
Room No 3010, Third Floor,
Institute of Liver Disease and Transplantation
No 7 CLC Works Road
Chromepet
Chennai 600044
Chennai
TAMIL NADU |
9729440890
rajangarg1985@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rela Institute and Medical Center, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Calculation of total psoas muscle area (sum of right and left posts muscle area) at L3-4 level intervertebral disc on CT scans done for any acute indication |
|
| ExclusionCriteria |
| Details |
Chronic illnesses like chronic liver and kidney diseases, malignancies, spinal trauma, myopathies and cerebral palsy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Formulation of age and gender based nomogram for total psoas muscle area for Indian Children |
Day-0 of CT scan - single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sarcopenia comparison of children with chronic disorders with the age and gender based nomogram values and their correlation with outcomes |
Day 30, Day 90, day 180, 1 year |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
01/05/2024 |
| 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="0"
Months="3"
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
|
Current literature strongly recommends sarcopenia and frailty assessment over routine anthropometric measurements to predict outcomes in any chronic illness and its treatment. All the currently available scales are based on western data. Unfortunately, there is no data on the normal range of muscle mass from our population and this skews comparison and outcomes.
In a first of its kind, we intend to develop an age and gender specific nomogram for normal muscle mass in children from the Indian subcontinent. The sum of psoas muscle area at L3-L4 intervertebral disc on CT scan of children who undergo CT for trauma or acute illness across age groups from 1-16 years are collected. We are looking to collect 1000 such scans to make a reliable nomogram. The data will be completely anonymised as only the age, gender and psoas muscle data is required.
This will enable an India-specific nomogram to accurately define frailty and sarcopenia in the pediatric population which will in turn help in predicting and prognosticating the nutritional status of children with any chronic pathology. The trend when charted will also help in assessment of reversal of sarcopenia |