| CTRI Number |
CTRI/2024/06/068415 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Vitamin D status of children with congenital heart disease who are admitted to the hospital. |
|
Scientific Title of Study
|
Vitamin D levels in hospitalised children with congenital heart disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritika |
| 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 |
7080432794 |
| Fax |
|
| Email |
rritika784@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virendra Kumar |
| 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 |
|
| Fax |
|
| Email |
drvkumar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritika |
| 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 |
7080432794 |
| Fax |
|
| Email |
rritika784@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics ,Maulana Azad Medical College,New Delhi ,India pin-110002 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics |
| Address |
Maulana Azad Medical College ,New Delhi,India,pin-110002 |
| 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 Ritika |
Lok Nayak Hospital |
Department Of Pediatrics,Maulana Azad Medical College And Associated Lok Nayak Hospital
New Delhi
DELHI |
7080432794
rritika784@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q20-Q28||Congenital malformations of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil
|
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 1month to 12years with congenital heart disease |
|
| ExclusionCriteria |
| Details |
Children with chronic liver or kidney disease ,malabsorption,inflammatory bowel disease or hyper parathyroidism
Children on anticonvulsants or systemic steroids
Children who have received vitamin D insufficiency/ deficiency treatment in the last 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of hospitalised children with congenital heart disease with Vitamin D deficiency,less than 12ng per ml |
On day of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity of heart failure using Modified Ross score and NT proBNP levels
Vitamin D levels in cyanotic and acyanotic group |
On day of admission |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/06/2024 |
| 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
|
This study is an observational study to find out the proportion of hospitalised children with congenital heart disease who have vitamin D deficiency and will be conducted in the Department of Pediatrics in Maulana Azad MedicalCollege and Associated Lok Nayak Hospital New Delhi.The primary objective will be to find out the proportion of hospitalised children with congenital heart who are deficient in Vitamin D .The secondary objective will be to study the association of Vitamin D levels and severity of heart failure using Modified Ross score and NTpro BNP levels and to compare the levels of Vitamin D in cyanotic and acyanotic group. Our hypothesis is that children with congenital heart disease have lower levels of vitamin D due to higher requirements , sedentary lifestyle, frequent hospitalisations etc. and that it can be associated with increased risk of hospitalisation, heart failure and overall poor outcome.
|