| CTRI Number |
CTRI/2025/04/085737 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying the link between Vitamin D levels and growth in individuals aged 10 to 14, using two growth indicators- one from x-ray (CVMI) and another from a growth related hormone (IGF-1) |
|
Scientific Title of Study
|
Assessment and correlation of Vitamin D level with growth status as measured by CVMI and IGF-1 level in 10-14 years old individuals. |
| 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 Manika Jaiswal |
| Designation |
Junior Resident 2nd year |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre |
| Address |
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, DIGDOH HILLS, HINGNA NAGPUR
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7506452370 |
| Fax |
|
| Email |
jaiswalmanika09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. ANANYA HAZARE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre |
| Address |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, DIGDOH HILLS, HINGNA 440019
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9890992170 |
| Fax |
|
| Email |
ananya.hazare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manika Jaiswal |
| Designation |
Junior Resident 2nd year |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre |
| Address |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS,RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, DIGDOH HILLS, HINGNA NAGPUR
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7506452370 |
| Fax |
|
| Email |
jaiswalmanika09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental college and Research centre, Digdoh Hills, Hingna, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Manika Jaiswal |
| Address |
Dept of Orthodontics and Dentofacial Orthopedics, Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Hingna road, Nagpur, INDIA 440019 |
| 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 Manika Jaiswal |
Ranjeet Deshmukh Dental College and Research centre |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, 1st floor, Ranjeet Deshmukh Dental College and Research Centre, Lata Mangeshkar Hospital, Digdoh Hills, Police Nagar, Hingna, 440019
Nagpur
MAHARASHTRA |
7506452370
jaiswalmanika09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Age of the patient between 10-14 years.
2.Patients having lateral cephalograms taken for orthodontic treatment.
3.Patient willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.History of systemic diseases, medication intake, craniofacial syndromes.
2.Patient not willing to perform blood test.
3.Patients who have taken Vitamin D supplements in last 2 years.
4.Patients who are currently on Vitamin D supplements.
• Patients with Endocrinal disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study aims to determine whether vitamin D levels are significantly associated with physical growth and maturation markers in children aged 10-14 years. |
at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To associate Vitamin D level with the body mass index.
b) To associate Vitamin D level with growth pattern.
c) To associate Vitamin D level with Skeletal malocclusion.
d) To associate level of Vitamin D with exposure to sunlight.
|
In a period of 18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/08/2025 |
| 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="5"
Days="30" |
|
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
|
This cross-sectional analytical study will evaluate 50 orthodontic patients ages between 10 to 14 years presenting to the Orthodontic Department. All the patients who have had lateral cephalograms obtained for their orthodontic treatment will be selected for the study. All the patients and their parents will be informed about the study and the parents will sign the informed consent forms. After obtaining the parents consent, questionnaire will be provided to the patient to analyze the dietary intake of Vitamin D and exposure to sunlight, patients will then undergo blood tests in the designated laboratory to determine their serum 25-hydroxy vitamin D level and IGF-1 level. The patients and their parents will be informed of the test results and will be educated about the role of vitamin D in the body. The test results will then be provided to the parents, and they will be referred for medical consultation if needed. To determine the skeletal age of patients, CVM stage analysis of the second, third and fourth cervical vertebrae (CV2-CV4) on lateral cephalograms will be performed. The investigator will be blinded to the chronological age and serum vitamin D level of patients and will independently determine the CVM stage and the skeletal age. Cervical vertebral maturation stage (C2-C4) will be evaluated, as presented by Baccetti modified protocol. The blood sample that we obtained will aid us to determine the level of Insulin like growth factor-1(IGF-1) with the help of DRG IGF-1 600 ELISA kit. The DRG IGF-1 600 ELISA Kit is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding. • Data will then be statistically compared to correlate level of Vitamin D with growth status of the patients. |