| CTRI Number |
CTRI/2023/09/057484 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
07/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Nutritional anemia among children aged 8-11years in schools of rural areas |
|
Scientific Title of Study
|
Prevalence of nutritional anemia among children aged 8-11years in schools of bengaluru rural areas-A cross sectional 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 |
Dr Anushri P |
| Designation |
Pediatrics- Junior Resident |
| Affiliation |
Department of Pediatrics |
| Address |
Department of Pediatrics,
BGS Global institute of medical sciences,
Dr Vishnuvardan road,
Kengeri, Bengaluru.
Bangalore
KARNATAKA
560060
India |
| Phone |
9740331726 |
| Fax |
|
| Email |
panushree96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh M |
| Designation |
Professor and Head |
| Affiliation |
Department of Pediatrics |
| Address |
Department of Pediatrics
BGS Global institute of medical sciences Dr Vishnuvardan road Kengeri Bengaluru.
Bangalore
KARNATAKA
560060
India |
| Phone |
9900111261 |
| Fax |
|
| Email |
rameshmalliah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anushri P |
| Designation |
Pediatrics- Junior Resident |
| Affiliation |
Department of Pediatrics |
| Address |
Department of Pediatrics
BGS Global institute of medical sciences,Dr Vishnuvardan road, Kengeri, Bengaluru
Bangalore
KARNATAKA
560060
India |
| Phone |
9740331726 |
| Fax |
|
| Email |
panushree96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics,
BGS Global institute of medical sciences,
Dr Vishnuvardan road,
Kengeri, Bengaluru. |
|
|
Primary Sponsor
|
| Name |
Dr Anushri P |
| Address |
BGS Global institute of medical sciences,Dr Vishnuvardan road,Kengeri,Bengaluru,560060 |
| 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 |
| DrAnushri P |
BGS Global Institute Of Medical Sciences |
Department of Pediatrics,Room num: 04, Ground floor,
BGS Global institute of medical sciences Vishnuvardan road, Kengeri, Bengaluru,560060
Bangalore
KARNATAKA |
09740331726
panushree96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 8-11years in schools of rural areas |
|
| ExclusionCriteria |
| Details |
-Hemolytic anemia
-Bleeding disorders
-Prior blood transfusion
-Congenital heart disease
-Renal disease
-Chronic medical illness
-Renal diseases
-Recent h/o malaria
-On iron supplements |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of anemia among 8-11years |
immediately after blood investigations |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cause of anemia whether nutritional or not |
after blood investigation and history, clinical examination |
|
|
Target Sample Size
|
Total Sample Size="452"
Sample Size from India="452"
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)
|
21/09/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross sectional study. This study is done to know the prevalence of anemia among children aged 8-11years.Children are selected as per exclusion and inclusion criteria. Study will be explained in detail to parents and head of the school and informed consent is taken. Demographic details, personal history, dietary history, anthropometry, general physical examination, systemic examination will be done and entered in pre-structured proforma. Data will be represented in the form of frequencies and proportions.
Study will help to know the prevalence of anemia in prepubertal age, which will be helpful in preventing anemia in pubertal age and also helps to know whether anemia is nutritional or not, if nutritional can be improved by good nutritional support and supplementation. |