| CTRI Number |
CTRI/2024/05/067782 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
In this study healthy children and adolescents of 5-16 years are group are taken to determine chronological age bone age and correlate them with serum IGF-1 levels. |
|
Scientific Title of Study
|
serum insulin like growth factor-1(IGF-1) levels in healthy children and adolescents, and its association with height velocity, chronological age and bone age: a one year, longitudinal 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 Naga Dakshata malepati |
| Designation |
MD Paedriatrics |
| Affiliation |
Kahers jawaharlal nehru medical college |
| Address |
Depatment of paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8374304130 |
| Fax |
|
| Email |
mndakshata@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi B R |
| Designation |
Assistant professor |
| Affiliation |
Kahers Jawaharlal Nehru medical college |
| Address |
Depatment of paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9900184188 |
| Fax |
|
| Email |
meenakshi.br@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naga Dakshata malepati |
| Designation |
MD Paedriatrics |
| Affiliation |
Kahers Jawaharlal Nehru medical college |
| Address |
Depatment of paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8374304130 |
| Fax |
|
| Email |
mndakshata@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Nehru Nagar, Belagavi
India, Karnataka, Belagavi
pincode-590001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College, KLE University, Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road, Belgaum, Karnataka, 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 Naga Dakshata Malepati |
KLEs Dr Prabhakar Kore Hospital, Belagavi |
Department of Paediatrics, Paediatric endocrinology,
Belgaum
KARNATAKA |
8374304130
mndakshata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children and adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
5-16 Years old healthy children and adolescents with normal height for age and normal weight for age selected from the schools of belagavi district |
|
| ExclusionCriteria |
| Details |
1. children with under nutrition
2. children with overweight or obesity
3. children with
-syndromic/non syndromic short stature
-growth hormone deficiency
-familial/idiopathic short stature
-skeletal dysplasia
-rickets
-chronic systemic illness, anemia
-uncorrected congenital heart disease |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine normative data of serum insulin like growth factor-1(IGF-1) levels in healthy children and adolescents between 5-16years of age |
To determine normative data of serum insulin like growth factor-1(IGF-1) levels in healthy children and adolescents between 5-16years of age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study serum IGF-1 levels in association with
1. bone age
2. chronological age
3. height velocity |
The study will be conducted over a span of one year |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
25/06/2024 |
| 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) |
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
|
The growth hormone-IGF-1 axis serves as a central endocrine governing growth and development in children and adolescents. During childhood, IGF-1 levels demonstrate a gradual increase with age, undergo a rapid surge during puberty. Many factors influencing IGF-1 levels, include genetics, age, sex, hormonal, environmental factors and puberty. Relying solely on chronological age based reference values for IGF-1 may not yield accurate assessments. serum IGF-1 levels serve as a direct reflection of growth hormone activity and overall nutritional status of an individual thereby making a valuable biomarker of malnutrition. Hence various diseases, chronic malnutrition, hormone deficiency and turner syndrome. Understanding the correlation between serum IGF-1 levels and parameters such as height velocity, chronological age, and bone age becomes imperative for a comprehensive evaluation of paediatric growth dynamics. Bone age an indicator of biological development, representing the degree of physiological maturity, being strongly associated with the pubertal growth spurt, secondary sexual development and menarche, often elevate with advanced IGF-1 levels. Timing and variability of pubertal progression accurate assessment of IGF-1 levels to chronological age and bone age becomes paramount. Correlation between serum IGF-1 levels and bone age has been the topic of interest amongst researchers. Thought many studies have undertaken on correlation of IGF-1 levels and chronological age, limited research exist on the correlation of IGF-1 level with chronological age, bone age and height velocity. Moreover, most correlation data pertains to population of western world which may not be relevant for our population. Our study intends to fill the knowledge gap by comprehensively studying serum IGF-1 levels in relation to bone age, chronological age, and height velocity comprising of Indian ethnicity-based data. |