| CTRI Number |
CTRI/2025/07/091486 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of nutrition problems among students (10 to 15 Years Old) in city and village schools of Belagavi” |
|
Scientific Title of Study
|
Assessment of micronutrient deficiencies among 10-15 years old school going adolescents in rural and urban areas of belagavi-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 Tatavarthy Mohit |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
Department of community medicine Jawaharlal Nehru Medical College, nehru nagar Belagavi,Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7995639866 |
| Fax |
|
| Email |
tmohit9809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Kavi |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
Department Of community medicine Jawaharlal Nehru Medical College, nehru nagar Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9538309785 |
| Fax |
|
| Email |
akavi@jnmc.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tatavarthy Mohit |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
Department of community medicine Jawaharlal Nehru Medical College, nehru nagar Belagavi,Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7995639866 |
| Fax |
|
| Email |
tmohit9809@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College Belagavi Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Tatavarthy Mohit |
| Address |
Department Of community medicine,Jawaharlal Nehru Medical College,Belagavi,Karnataka 590010 |
| 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 Tatavarthy Mohit |
Jawaharlal Nehru Medical College Belagavi |
Department Of community medicine,Jawaharlal Nehru Medical College,Belagavi,Karnataka 590010
Belgaum
KARNATAKA |
7995639866
tmohit9809@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health School going Adolescents from 10-15 years old |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1)Adolescents aged 10–15 years
2)Currently enrolled in schools within Belagavi taluk
3)Students who provide assent and whose parents/guardians provide informed consent
|
|
| ExclusionCriteria |
| Details |
1)Adolescents with known chronic illnesses (e.g., thalassemia, chronic kidney disease, inflammatory bowel disease, etc.) that can affect micronutrient levels
2)Adolescents on nutritional supplementation apart from Weekly Iron and Folic Acid Supplementation (WIFS) in the past 3 months
c) Adolescents with acute illness (ex: Fever, acute gastroenteritis, etc) at the time of data collection
d) Adolescents with known bleeding disorders
e) Adolescents having visual and hearing disabilities and/or mental illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine prevalence of micronutrient deficiencies among school going adolescents in Belagavi |
50 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the determinants of micronutrient deficiencies among school going adolescents among 10-15 years in Belagavi |
50 weeks |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
10/08/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response (Others) - De-Identified data including age,sex, anthropometric measures,levels,and micronutrient levels
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Upon reasonable request and approval by the Institutional Ethics committee.Data sharing will require a data use agreement
- For how long will this data be available start date provided 01-06-2027 and end date provided 31-05-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The severe social, health, and economic consequences of the micronutrient deficiencies underscore the urgency of addressing this issue among adolescents. This population is not only a significant demographic group but also pivotal to India’s future development. By assessing the prevalence and implications of deficiencies in iron, calcium, zinc, vitamin B12, and folate among school-going adolescents, we aim to generate evidence to inform strategies for improving adolescent health and well-being. Anemia being a significant health problem affecting the physical, mental and social wellbeing among adolescents which has an impact on the overall health as well as academic performance and not being addressed efficiently with Iron supplements alone. We need to further look for micronutrient supplementation among adolescents which may have long term implication on health and wellbeing. This study will highlight the burden of hidden hunger among adolescents and help to plan specific nutritional interventions. |