| CTRI Number |
CTRI/2024/10/075167 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Environmental exposure to Lead resulting in improper development in young children |
|
Scientific Title of Study
|
Prevalence High Blood Lead Level(BLL) amongst preschool children of Belagavi District and its Impact on Neuro development |
| 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 Rajan Patil R Patil |
| Designation |
Professor |
| Affiliation |
JNMC, KLE University, KAHER, Belguam 590010 |
| Address |
Woman and Child Health Research Unit.
JNMC, Neharu Nagar, Belgaum 590010, Karnatak
Belgaum
KARNATAKA
590010
India |
| Phone |
9445811610 |
| Fax |
|
| Email |
rajanpatil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan Patil R Patil |
| Designation |
Professor |
| Affiliation |
JNMC, KLE University, KAHER, Belguam 590010 |
| Address |
Woman and Child Health Research Unit.
JNMC, Neharu Nagar, Belgaum 590010, Karnatak
Belgaum
KARNATAKA
590010
India |
| Phone |
9445811610 |
| Fax |
|
| Email |
rajanpatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan Patil R Patil |
| Designation |
Professor |
| Affiliation |
JNMC, KLE University, KAHER, Belguam 590010 |
| Address |
Woman and Child Health Research Unit.
JNMC, Neharu Nagar, Belgaum 590010, Karnatak
Belgaum
KARNATAKA
590010
India |
| Phone |
9445811610 |
| Fax |
|
| Email |
rajanpatil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research, Neharu Nagar, Belgaum, 590010 |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
JNMC, Neharu Nagar, Belguam, Karnataka pin code 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 Rajan R Patil |
Basic Science Research Centre |
Jawaharlal,Neharu medical college, Department of Woamn and Child Health, Research unit, 3rd floor, Room no, Neharu nagar Karnataka 590010
Belgaum
KARNATAKA |
9445811610
rajanpatil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Instititutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
F70-F79 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria: Anganwadi going children aged 3-6 years, whose parents are consenting
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria: Children with serious health issues, and children on immunosuppressive drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lead Toxicity disorder |
at the base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood lead level and Neuro delopment disorder |
at the time of assessment |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
25/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
- Who will be able to view these files?
Response (Others) - RESEARCH
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajanpatil@yahoo.com].
- For how long will this data be available start date provided 25-10-2024 and end date provided 30-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
The
tThe toxic metal lead
(Pb) is widely present in the environment and workplaces, posing a threat to
human health. It can cause damage to the nervous system and disrupt
development. Childhood exposure to lead has been linked to long-term effects
such as neurological disorders, cognitive delays, and lower educational
achievement, which are irreversible. Lead poisoning can also cause symptoms
like stomach cramps, dizziness, headaches, and constipation.
Considering this, the
proposed study aims to investigate the relationship between the neurological
development, and high blood lead levels in children aged 3 to 6 years. This age
group is particularly vulnerable to lead exposure due to their developing
bodies and tendency to put objects or hands in their mouth.
The study will be done in two installments in Part-1
basic prevalence of BLL and Screening for Neuro development behavious among
children in the field.. The DBS filter paper will be preserved in deep cold storage and the
genetic studies will be done on preserved blood samples | |