| CTRI Number |
CTRI/2025/09/094602 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Revised Cross-sectional Growth Curves for Height Weight and Body Mass Index |
|
Scientific Title of Study
|
Development of Updated Growth References for Indian Children and Adolescents (0–18 Years): A Multicenter 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 Anuradha Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI) |
| Address |
Lower Ground Floor, Jehangir Hospital, 32 Sassoon Road, Pune, Maharashtra, India Lower Ground Floor, Jehangir Hospital, 32 Sassoon Road, Pune, Maharashtra, India Pune MAHARASHTRA 411001 India |
| Phone |
08975230213 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anuradha Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI) |
| Address |
Lower Ground Floor, Jehangir Hospital, 32 Sassoon Road, Pune, Maharashtra, India Lower Ground Floor, Jehangir Hospital, 32 Sassoon Road, Pune, Maharashtra, India Pune MAHARASHTRA 411001 India |
| Phone |
08975230213 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anuradha Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI) |
| Address |
Lower Ground Floor, Jehangir Hospital, 32 Sassoon Road, Pune, Maharashtra, India Lower Ground Floor, Jehangir Hospital, 32 Sassoon Road, Pune, Maharashtra, India Pune MAHARASHTRA 411001 India |
| Phone |
08975230213 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
HCJMRI |
| Address |
33, Sassoon Road, Jehangir Hospitals, Pune, Maharashtra,411001 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chirantap Oza |
EndoGrow Pediatric and Adolescent Endocrine Center |
205 vision Complex, Besides legends of punjab,Panjrapole char rasta, Ambawadi, Ahmedabad 380015. Ahmadabad GUJARAT |
9023094004
chirantap@gmail.com |
| Dr Saurabh Uppal |
Growth Clinic |
First floor,192 Gujral Nagar, Jalandhar city, 144001 Jalandhar PUNJAB |
9357493570
drsaurabhuppal@gmail.com |
| Dr Hriday De |
Institute of Child Health |
11,Dr. Biresh Guha Street, Kolkata- 700017, Park Circus, Kolkata, West Bengal , Ground Floor , Project Room (Room No. 113) Kolkata WEST BENGAL |
97358 46215
hridayde2010@gmail.com |
| Dr Shaila Pachapure |
KLEs Dr. Prabhakar Kore hospital |
Quarter A14/8, JNMC campus, Behind dental college, Nehru Nagar, Belagavi 590010 Belgaum KARNATAKA |
9632446393
drshailams@gmail.com |
| Dr Vijay Jaiswal |
LLRM medical college |
Dr Anupama Verma-Head of Department Pediatric, LLRM medical college, Meerut, UP, Pin 250004 Meerut UTTAR PRADESH |
9808959959
kinjalvijay@yahoo.com |
| Dr Hemchand Prasad |
Mehta Multispeciality Hospitals India Pvt Ltd |
No.2, McNichols Road, 3rd Lane, Chetpet, Chennai-600031 Chennai TAMIL NADU |
9884984280
pediatricendocrinology.mehta@gmail.com |
| Dr Nikhil Shah |
Sai kripa childrens hospital |
Road no 1, Opp bmc office, Chembur, Mumbai 400071 Mumbai MAHARASHTRA |
9833443740
nikhilshah1507@gmail.com |
| Dr Aashish Sethi |
Shri Mahant Indresh Hospital |
House no 20, Lane no 2,Dron puri, GMS ROAD, Dehradun, 248001 Dehradun UTTARANCHAL |
9818038469
Dr.aashishsethi@gmail.com |
| Dr Kiran Meena |
ShriKripa Clinics |
31,32, SKIT college road, Ramanagaria, Jagatpura, Jaipur -302017 Jaipur RAJASTHAN |
7733066261
drkiran2172@gmail.com |
| Dr Nikhil Lohiya |
Silver Lining Pediatric Super Specialty Center |
2nd Floor, K K Business Plaza, Lokmat Square, Ramdaspeth Nagpur- 440010 Nagpur MAHARASHTRA |
7358565686
drnnlohiya@gmail.com |
| Dr Ankita Maheshwri |
Sri Aurobindo medical college and post graduate institute |
222, 2 nd floor , benchmark building, Opposite Satya Sai school Satya Sai square, Indore (Madhya Pradesh) 452010 Indore MADHYA PRADESH |
7046370787
ankitamaheshwari23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jehangir Clinical Development Center Pvt. Ltd. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Without any comorbidities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers |
|
| ExclusionCriteria |
| Details |
Without any comorbidity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
For the first time growth references will be available for Indian children from 0-5 years.
Updated references will be available for 5-18 year old Indian children
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
These data will be useful not only for clinical growth monitoring but also for researchers.
|
Yearly data |
|
|
Target Sample Size
|
Total Sample Size="31122" Sample Size from India="31122"
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)
|
01/10/2025 |
| 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="1" Days="1" |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anuradhavkhadilkar@gmail.com].
- For how long will this data be available start date provided 02-12-2027 and end date provided 02-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Growth monitoring is a vital component of child health assessment, serving as an early indicator of nutritional status and growth-related disorders. While international growth references, such as the WHO Child Growth Standards (for children under five), WHO Growth References (for ages 5–19) and the 2015 IAP growth charts are commonly used in India, they may not accurately reflect the growth of present day Indian children. Several studies have highlighted the limitations of applying global/ dated standards to Indian populations, including the risk of overestimating undernutrition. Existing Indian growth references, such as those developed by Agarwal et al. (1992), Khadilkar et al. (2009, 2012), and the IAP Growth Charts (2015), have contributed significantly to pediatric growth assessment in India. However, these data were primarily derived from older cohorts and urban, affluent populations. They may not adequately capture recent secular trends in growth patterns, especially in the context of India’s ongoing nutrition transition and the rising prevalence of overweight and obesity in children and adolescents. The absence of up-to-date, comprehensive, and nationally representative growth references limits the accuracy of nutritional assessments and hinders effective public health planning. Therefore, there is a clear and urgent need to develop updated growth reference data for Indian children and adolescents aged 0–18 years, based on contemporary anthropometric measurements. Such data will enhance clinical decision-making and provide a robust foundation for nutrition policies, school health programs, and research.
|