| CTRI Number |
CTRI/2024/03/064073 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of plastics exposure in early puberty. |
|
Scientific Title of Study
|
Association of endocrine disruptors (plasticizers) with early puberty in Indian children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binita Goswami |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 255
Department of Biochemistry
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
binita.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binita Goswami |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 255
Department of Biochemistry
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9810592004 |
| Fax |
|
| Email |
binita.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binita Goswami |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 255
Department of Biochemistry
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9810592004 |
| Fax |
|
| Email |
binita.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR-DHR, V. Ramalingaswami Bhawan PO Box 4911, Ansari Nagar New Delhi- 110 029 |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
V RAMALINGASWAMI BHAWAN, PO BOX NO. 4911 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anita Devi |
DR RAJENDRA PASAD MEDICAL COLLEGE |
Room: 521, Department of Biochemistry, Paraclinical Block, Dr RP Medical College, Tanda, Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH |
9868343255
devianita2003@gmail.com |
| Dr Binita Goswami |
MAULANA AZAD MEDICAL COLLEGE |
Room: 255, 2nd Floor, Department of Biochemistry, Pathology Block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg, Delhi
Central
DELHI |
9810592004
binita.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC Dr Rajendra Prasad Government Medical College |
Approved |
| IEC MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age-matched healthy children residing in same geographical area |
| Patients |
(1) ICD-10 Condition: E301||Precocious puberty, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Cases will be identified as children with either gender who present with early or precocious puberty defined in girls as onset of thelarche, pubarche or adrenarche before 8 years of age and in boys as increase in testicular volume greater than 4mL, pubarche or adrenarche before 9 years of age. Children labeled as idiopathic precocious puberty (due to both central and peripheral causes) will be included as Cases. |
|
| ExclusionCriteria |
| Details |
1.Children born small for gestational age defined as birth weight below 10th centile.
2.Children with organic cause of early or precocious puberty like intracranial malformation, infection, tumors or congenital adrenal hyperplasia or gonadal tumors.
3.Children previously diagnosed with any hormonal disorder or on any steroid drugs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urinary and serum levels of plasticizer like bisphenol-A, plasma phthalate in cases and controls |
Single point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between bisphenol-A, plasma phthalate levels & serum FSH, LH & kisspeptin expression between control & cases
|
Single point |
| Correlation between plasticizer levels & anthropometry & serum leptin levels |
Single point |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="171"
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)
|
01/04/2024 |
| 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="3"
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 - NO
|
|
Brief Summary
|
A
secular trend in the age of Pubertal onset is discernible globally. One of the
implicated factors other than nutrition and genetics includes exogenous compounds with endocrine active properties that
interfere with endogenous hormone action. These Endocrine Disrupting Compounds
(EDCs) can bind hormone receptors and affect their synthesis, transport,
metabolism, and/or elimination. This study is planned to compare the levels of
these plasticizers in children who demonstrated features of early/ precocious
puberty and compare with age-matched healthy controls with normal puberty who
reside in the same geographical area. The levels will also be correlated with
puberty-governing neuropeptide like Kisspeptin. The study will be a
multicentric study that will recruit 31 cases and 62 controls during the study
period. All participants will be subjected to urine and blood tests
at one point in time. Our study
attempts to evaluate the role of EDC exposure on pubertal onset with correction
of nutritional status which is a major confounder. It will help us determine a functional impact of EDC status on
hypothalamic-pituitary axis by measurement of Kisspeptin levels |