| 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
|
|
|
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
|
|
|
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
|
|
|
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. |