| CTRI Number |
CTRI/2025/03/082035 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
metabolic stress in children with Down syndrome |
|
Scientific Title of Study
|
Markers of metabolic and oxidative stress in children with Down syndrome |
| 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 Arshida Husain |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College And Associated Lok Nayak Hospital
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8528253831 |
| Fax |
011-23236031 |
| Email |
arshuhusain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Kapoor |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College And Associated Lok Nayak Hospital
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9868846606 |
| Fax |
011-23236031 |
| Email |
drseemakapoor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshida Husain |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College And Associated Lok Nayak Hospital
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8528253831 |
| Fax |
011-23236031 |
| Email |
arshuhusain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics ,Maulana Aazd Medical College , New Delhi , 110002 |
|
|
Primary Sponsor
|
| Name |
Department Of Pediatrics Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital 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 |
| Dr Arshida Husain |
Lok Nayak Hospital |
Department of Pediatrics
Maulana Azad Medical College And Associated Lok Nayak Hospital
New Delhi
Department of Pediatrics
Maulana Azad Medical College And Associated Lok Nayak Hospital
New Delhi
New Delhi
DELHI |
08528253831
011-23236031
arshuhusain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maualana Azad Medical College And Associated Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Case - Children diagnosed with Down syndrome in this age group
Control - Children with no medical illness - age and gender matched. |
|
| ExclusionCriteria |
| Details |
CASE - Children with mosaic trisomy on karyotype.
Control - Childen with obesity and pre existing diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Means levels of Leptin and Adiponectin in children with DOWN syndrome
Mean levels of Superoxide dismutase in children with Down syndrome.
Association between the levels of these markers including lipid profile with BMI and hepatic steatosis as estimated with shear wave elastogaphy. |
Means levels of Leptin and Adiponectin in children with DOWN syndrome at first visit or day 1
Mean levels of Superoxide dismutase in children with Down syndrome on first visit Association between the levels of these markers including lipid profile with BMI and hepatic steatosis as estimated with shear wave elastogaphy on first visit . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Means levels of Leptin & Adiponectin in children with DOWN syndrome
Mean levels of Superoxide dismutase in children with Down syndrome.
Association between the levels of these markers including lipid profile with BMI & hepatic steatosis as estimated with shear wave elastogaphy. |
On the day of OPD visit or day 1 |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
20/03/2025 |
| 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
|
This study is a observational case control study to assess the metabolic and oxidative stress in children with Down Syndrome in comparison with age and gender matched healthy control population by estimating the mean levels of Leptin , Adiponectin and Superoxide Dismutase levels .Also the level of hepatic steatosis as measured by shear wave elastography . The study will be conducted in OPD’s and IPD’s of Department of Pediatrics in Maulana Azad Medical College and Associated Lok Nayak Hospital , New Delhi. The objective of the study is to compare levels of Leptin , Adiponectin , SOD in children with Down syndrome with their healthy control siblings and to assess liver steatosis by shear wave elastography on ultrasonography . The hypothesis of our study is that children with Down Syndrome are at risk of high levels of oxidative stress which is linked to atheroscelerosis development , neurodegeneration , cell aging and cancer . |