| CTRI Number |
CTRI/2025/04/084870 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Characterisation of the micronutrient profile among Indian adolescent girls and development of strategies to tackle deficiencies |
|
Scientific Title of Study
|
Micronutrients and body composition among young school going adolescent (13-15y age) girls. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suvarna Patil |
| Designation |
Medical Director |
| Affiliation |
BKL Walawlkar Hospital, Diagnostics and Research Centre |
| Address |
Centre for Adolescent Health and Nutrition, Romm No-100
BKL Walawlkar Hospital, Diagnostics and Research Centre
Sawarde
Taluka-Chiplun
District-RatnagiriI
Ratnagiri
MAHARASHTRA
415606
India |
| Phone |
9921251695 |
| Fax |
|
| Email |
director.bklwrmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Bhat |
| Designation |
Scientist |
| Affiliation |
BKL Walawlkar Hospital, Diagnostics and Research Centre |
| Address |
Centre for Adolescent Health and Nutrition, Romm No-100
BKL Walawlkar Hospital, Diagnostics and Research Centre
Sawarde
Taluka-Chiplun
District-RatnagiriI
Ratnagiri
MAHARASHTRA
415606
India |
| Phone |
9370427047 |
| Fax |
|
| Email |
rohitbhat@bklwrmc.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suvarna Patil |
| Designation |
Medical Director |
| Affiliation |
BKL Walawlkar Hospital, Diagnostics and Research Centre |
| Address |
Centre for Adolescent Health and Nutrition, Romm No-100
BKL Walawlkar Hospital, Diagnostics and Research Centre
Sawarde
Taluka-Chiplun
District-RatnagiriI
Ratnagiri
MAHARASHTRA
415606
India |
| Phone |
9921251695 |
| Fax |
|
| Email |
director.bklwrmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bill and Melinda gates Foundation |
|
|
Primary Sponsor
|
| Name |
Bill & Melinda Gates Foundation |
| Address |
Unit 103A Right Wing, Unit 103B1/2/3/4 Left Wing, 3rd Floor, Capital Court Building, Olof Palme Marg, Munirka, New Delhi, 110067, India. |
| Type of Sponsor |
Other [Private foundation] |
|
|
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 Suvarna Patil |
BKL Walawalkar Hospital diagnostics and Research Centre |
Centre for Adolescent Health and Nutrition, Romm No-100
BKL Walawlkar Hospital, Diagnostics and Research Centre
Sawarde
Taluka-Chiplun
District-RatnagiriI
Ratnagiri
MAHARASHTRA |
9921251695
director.bklwrmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BKLWalawalkarHopsitalDiagnosticandResearchCentre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No chronic diasease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Female |
| Details |
Physically healthy and mentally fit. |
|
| ExclusionCriteria |
| Details |
1. Chronic disease like diabetes, hypertension and cardiovascular abnormalities, cancer, thyroid disorders at the time of recruitment
2. Cognitive and intellectual disabilities
3. Psychological and behavioral problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Micronutrient deficiency |
at enrollment and at 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| body composition |
at enrollment & at 2 years |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/06/2025 |
| 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="0"
Months="6"
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
|
Adolescence is a period of rapid growth creating increased demand for energy and nutrition. It has been postulated that nutritional deficiency during adolescence can have a negative impact on the future health of the individual. This is particularly important in girls as malnutrition will also affect their offspring. Negative effects of adolescent malnutrition can persist throughout the reproductive life. Adolescence can be an opportunity to correct nutritional deficiencies and thus possibly reduce the risks of development of adverse health outcomes in later adulthood. Despite its importance, research into adolescent nutrition has been relatively neglected. There are large knowledge gaps about the nutritional status of adolescents and how it influences growth, neuro-development, later disease risk and the health of the next generation. We plan to generate data on micronutrient deficiencies among young (13-15y old) school going adolescent girls |