FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050455 [Registered on: 07/03/2023] Trial Registered Prospectively
Last Modified On: 06/03/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the magnitude of early puberty among girls in the preadolescent phase( 6-9 years) 
Scientific Title of Study   Determining the prevalence and risk factors associated with precocious puberty among pre-pubertal girls in Mumbai 
Trial Acronym  PREPPAG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suchitra Surve 
Designation  Scientist C, Head of Department of Child Health Research 
Affiliation  ICMR-NIRRCH  
Address  Child Health Clinic, Department of Child Health Research National Institute for Research in Reproductive and Child Health, Indian Council of Medical Research, J.M. Street, Parel, Mumbai, 12

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192029  
Fax    
Email  surves@nirrh.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suchitra Surve 
Designation  Scientist C, Head of Department of Child Health Research 
Affiliation  ICMR-NIRRCH  
Address  Child Health Clinic, Department of Child Health Research National Institute for Research in Reproductive and Child Health, Indian Council of Medical Research, J.M. Street, Parel, Mumbai, 12

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192029  
Fax    
Email  surves@nirrh.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Suchitra Surve 
Designation  Scientist C, Head of Department of Child Health Research 
Affiliation  ICMR-NIRRCH  
Address  Child Health Clinic Department of Child Health Research National Institute for Research in Reproductive and Child Health, Indian Council of Medical Research, J.M. Street, Parel, Mumbai, 12

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192029  
Fax    
Email  surves@nirrh.res.in  
 
Source of Monetary or Material Support  
ICMR-National Institute for research in reproductive and Child Health 
 
Primary Sponsor  
Name  ICMR-National Institute for research in reproductive and Child Health 
Address  Jehangir Merwanji Street, Parel, Mumbai-400 012  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suchitra Surve  Child Health Clinic, ICMR-NIRRCH  Child Health Clinic, ICMR-NIRRCH,36/2507, Abhyuday Nagar, Near Post Office, Kalachowki, Mumbai - 400033
Mumbai
MAHARASHTRA 
02224192029

surves@nirrh.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICMR-NIRRCH ETHICS COMMITTEE FOR HUMAN STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Girls in the age group of 6-9 years in Municipal and private schools in community 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Female 
Details  Girls in the age group of 6-9 years in municipal and private schools in community
Precocious puberty case definition: Girls presenting with one of the following which has onset <8 YEARS:
TANNER STAGE 2 BREAST BUDDING AND/OR
PUBIC HAIR GROWTH AND/OR
AXILLARY HAIR AND/OR
MENARCHE 
 
ExclusionCriteria 
Details  Girls of parents who are not willing to give consent 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Magnitude and risk factors associated early Puberty in community
2. Diagnose precautious puberty and intervene early
3. Acceptability and Perceptions of parents towards diagnosis and treatment –Generate awareness among gatekeepers
 
Preparatory phase- 3 months
Data Collection phase-15 months
Data anlysis-3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Magnitude and risk factors associated early Puberty in community   Preparatory phase- 3 months
Data Collection phase-15 months
Data anlysis-3 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   13/03/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


Background

Precocious puberty (PP) is defined as the appearance of secondary sex characteristics before age 8 years in girls. It may manifest with either development of all the secondary sexual features (progressive PP) or as isolated premature thelarche, adrenarche or menarche. Environmental variables, weight, foetal nutrition, childhood dietary habits, physical activity, psychological factors, genetic factors and/or endocrine disrupting chemicals are known to affect timing of puberty.

There has been ethnic and geographical variation in timing of puberty globally. It is seen that very few prospective studies have been undertaken globally to understand prevalence of PP and majority studies have focussed only retrospective assessment on basis of early menarche. There is lack of information on prevalence, associated factors, EDCs as risk factors of early puberty from India.  Recent increase in incidence of childhood obesity and precocity during pandemic times has been reported in Indian newspapers. Hence, there is an urgent need of evidence on magnitude and risk factors associated with precocious puberty in Indian setting. Therefore, the present study is planned to determine the prevalence and risk factors associated with Precocious puberty among   pre-pubertal girls in Mumbai

Novelty

There has been ethnic and geographical variation in timing of puberty globally. However, majority studies have focussed only retrospective assessment of precocious puberty on basis of early menarche, especially with respect to studies in India. Majority studies have focussed on visual grading of breast stages. There is limited information on pubertal staging to document a trend to earlier maturation. Also, there is lack of information on prevalence, associated factors and determinants of early puberty from India  It is crucial to    puberty timely to initiate treatment as intervention is  not possible at later stage.

There is an urgent need of evidence on magnitude and risk factors associated with precocious puberty in Indian setting

Objectives

Primary Objective

To determine the prevalence of precocious puberty (Premature thelarche, adrenarche and menarche) among girls in the age group of 6-9 years

Secondary Objective

1.   To evaluate the risk factors associated with precocious puberty among girls in the age group of 6-9 years

2. To assess the knowledge about pubertal changes, health seeking behavior and attitude towards imparting pubertal information to girls among mothers

3.   To evaluate association of precocious puberty and exposure of endocrine disrupting chemicals

 

Methods

A prospective study will be carried out at community Clinic over a period of 2 years. Approximately 1000 girls in the age group of 6 -9 years from the schools in the vicinity with will be included.

Girls with diagnosis of early puberty will undergo detail History and Baseline hormonal investigations, USG, Bone age will also be recorded.  Baseline values of Kisspeptin, Neurokinin B, Neuropeptide Y and MKRN3 protein will be estimated. The levels will be repeated at the end of treatment to evaluate therapeutic relevance.

Expected Outcome

The study will help us to understand the determinants of ICPP and incomplete puberty and explore Clinical and therapeutic relevance.

 
Close