| CTRI Number |
CTRI/2024/04/066157 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prevalent study |
| Study Design |
Other |
|
Public Title of Study
|
Nutritional consideration for differently abled children from Kodagu district |
|
Scientific Title of Study
|
Nutritional assessment of differently abled children of Kodagu based on a sustainable dietary recommendation: An invivo 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 |
PUZHEKADAVIL KRISHNALEELA JOSHY |
| Designation |
Post graduate student |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of pediatric and preventive dentistry Room 8 K K campus Maggula village Virajpet Kodagu
Karnataka 571218
India
Coorg institute of dental sciences Department of pediatric and preventive dentistry Room 8 K K campus Maggula village Virajpet
Kodagu
Karnataka 571218
India
Kodagu
KARNATAKA
571218
India |
| Phone |
07411071909 |
| Fax |
|
| Email |
drkrishnaleelajoshy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PUZHEKADAVIL KRISHNALEELA JOSHY |
| Designation |
Post graduate student |
| Affiliation |
coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of pediatric and preventive dentistry Room 8 K K campus Maggula village Virajpet Kodagu Karnataka 571218
India
Coorg institute of dental sciences Department of pediatric and preventive dentistry Room 8 K K campus Maggula village Virajpet Kodagu Karnataka 571218
India
Kodagu
KARNATAKA
571218
India |
| Phone |
07411071909 |
| Fax |
|
| Email |
drkrishnaleelajoshy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHANTHALA B M |
| Designation |
Professor |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of Pediatric and preventive dentistry Room 8 K K campus Maggula village Virajpet
Kodagu karnataka 571218
India
Coorg institute of dental sciences Department of Pediatric and preventive dentistry Room 8 KK campus Maggula village Virajpet
Kodagu Karnataka 571218
India
Kodagu
KARNATAKA
571218
India |
| Phone |
9901452918 |
| Fax |
|
| Email |
shanthalapedo@cids.edu |
|
|
Source of Monetary or Material Support
|
| Coorg institute of dental sciences K K Campus Maggula Virajpet Karnataka Kodagu |
|
|
Primary Sponsor
|
| Name |
PUZHEKADAVIL KRISHNALEELA JOSHY |
| Address |
Coorg institute of dental sciences Depatment of Pediatric and preventive dentistry Room 8 K K Campus Maggula Virajpet
Karnataka Kodagu 571218
India |
| 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 Krishna Leela Joshy |
Coorg institute of dental sciences. |
Coorg institute of dental sciences. Department of Pediatric and preventive dentistry. K.K campus, Maggula village, Virajpet.
Kodagu
KARNATAKA |
7411071909
drkrishnaleelajoshy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board ,Coorg Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Special children with conditions like Cerebral Palsy, Mental Retardation, Autism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Special children with disabilities like mental retardation , Cerebral palsy, down syndrome , speech and hearing disability, Autism, visual impairment and learning disability who were willing to participate in the survey |
|
| ExclusionCriteria |
| Details |
Children with no disability , special children who were not willing to participate in the study and special children above 14 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nutritional status based on their diet practice |
At the time of observation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional demands of the participants can be assessed. |
One time
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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)
|
01/06/2024 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Appropriate nutritional guidelines will be assessed for the differently abled children considering their medical requirement needs and diet practices from three special centers in Coorg. |