| CTRI Number |
CTRI/2023/03/050277 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
31/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Nutritional assessment of children in selected government schools of Chengalpatu district |
|
Scientific Title of Study
|
Assessment of nutritional status of children studying in Government primary schools in Chengalpatu district - A community based cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Abirami |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16 Department of Kuzhanthai Maruthuvam National Institute of Siddha Tambaram Sanatorim
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9884657317 |
| Fax |
22381314 |
| Email |
abiramipugaz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Suresh |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16 Department of Kuzhanthai Maruthuvam National Institute of Siddha Tambaram Sanatorim
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
22381314 |
| Email |
drsureshherbal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Abirami |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16 Department of Kuzhanthai Maruthuvam National Institute of Siddha Tambaram Sanatorim
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9884657317 |
| Fax |
22381314 |
| Email |
abiramipugaz@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National /institute of Siddha |
| Address |
Room no 16, Department of Kuzhanthai Maruthuvam, National
Institute of Siddha, Tambaram sanatorium |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Abirami |
Panchayat Union Middle School |
Class room 1-5, Keezhathivaakam, Acharapaakam block.
Kancheepuram
TAMIL NADU |
9884657317
22381314
abiramipugaz@gmail.com |
| Dr P Abirami |
Panchayat Union Primary School |
Class room 1-5, Orathy, Acharapaakam block.
Kancheepuram
TAMIL NADU |
9884657317
22381314
abiramipugaz@gmail.com |
| Dr P Abirami |
Panchayat Union Primary School |
Class room 1-5, Vadamanipakkam, Acharapaakam block.
Kancheepuram
TAMIL NADU |
9884657317
22381314
abiramipugaz@gmail.com |
| Dr P Abirami |
Panchayat Union Primary School |
Class room 1-5, Vepankaaranai, Acharapaakam block.
Kancheepuram
TAMIL NADU |
9884657317
22381314
abiramipugaz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| District Educational Office |
Approved |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School children between 5 and 10 years |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Government School going children aged between 5-10 years.
Children willing to participate in the study.
Children giving consent through parents.
|
|
| ExclusionCriteria |
| Details |
School going children on treatment for any other illness. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nutritional status of children studying in Government Primary School will be analysed |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation of nutritional status of Children and their Dietary intake will be obtained |
6 months |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
Final Enrollment numbers achieved (Total)= "380"
Final Enrollment numbers achieved (India)="380" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2023 |
| Date of Study Completion (India) |
06/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a community based cross sectional study to assess the nutritional status of children studying in Government primary schools in Chengalpatu district. 380 children from different schools of Government primary schools in Chengalpatu district will be selected based on inclusion and exclusion criteria. Height, Weight and BMI of children are recorded and assessed by standards given by Indian academy of Pediatrics. Data will be collected from the selected subjects using the Subjective Global Nutritional Assessment (SGNA) questionnaire. All collected data will be entered into computer using MS excel software by the investigator. The data will be analyzed using STATA software under the guidance of the Guide and Statistician. The level of significance will be 0.05. Nutritional status of children studying in Government Primary School will be analysed. Relation of nutritional status of Children and their Dietary intake will be obtained.
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