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CTRI Number  CTRI/2025/05/086997 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 13/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study Of Premature Canities For Its Association With Haemoglobin, Serum Ferritin, Vitamin B12, Calcium And Vitamin D3 Levels 
Scientific Title of Study   A Cross-Sectional Analytical Study Of Premature Canities For Its Association With Haemoglobin, Serum Ferritin, Vitamin B12, Calcium And Vitamin D3 Levels 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijay Kumar Sharma 
Designation  Post graduate Resident  
Affiliation  Goverment medical college, kota 
Address  Department of dermatology, Room no 18,new medical college hospital, rangbadi road, kota, rajasthan

Kota
RAJASTHAN
324010
India 
Phone  8740968049  
Fax    
Email  vijaysharma101294@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devendra Kumar Yadav 
Designation  senior professor 
Affiliation  Goverment medical college, kota 
Address  Department of dermatology,Room no 18, New medical college hospital ,Rangbadi road, kota,Rajasthan.

Kota
RAJASTHAN
324010
India 
Phone  9414251864  
Fax    
Email  devendrayadav73@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devendra Kumar Yadav 
Designation  senior professor 
Affiliation  Goverment medical college, kota 
Address  Department of dermatology,Room no 18, New medical college hospital ,Rangbadi road, kota,Rajasthan.

Kota
RAJASTHAN
324010
India 
Phone  9414251864  
Fax    
Email  devendrayadav73@gmail.com  
 
Source of Monetary or Material Support  
Goverment medical college, kota,rajasthan,India,324010. 
 
Primary Sponsor  
Name  vijay Kumar Sharma 
Address  Department of dermatology,Room no 18, New medical college hospital ,Rangbadi road, kota,Rajasthan,India,324010. 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Devendra Kumar Yadav  Government Medical College, Kota.  Department of dermatology,Room no 18, New medical college hospital ,Rangbadi road.
Kota
RAJASTHAN 		 9414251864

devendrayadav73@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, GMC,Kota  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L679||Hair color and hair shaft abnormality, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients less than 25 years of age with minimum 5 gray hair fibre on scalp 
 
ExclusionCriteria 
Details  1. Greying of hair as a part of other conditions such as vitiligo and or cutaneous disease involving scalp.
2.Genetic disorders associated with greying of hair.
3.History of use of hair dye in past six months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Haemoglobin
2 Serum ferritin
3 Vitamin B12
4 Calcium
5 Vitamin D3 		 1 Haemoglobin at baseline
2 Serum ferritin at baseline
3 Vitamin B12 at baseline
4 Calcium at baseline
5 Vitamin D3 at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/06/2025 
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="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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vijaysharma101294@gmail.com].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 01-07-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This Study Aims At Finding Any Association Between Entities Like Haemoglobin, Serum Ferritin, Vitamin B12 ,Calcium And Vitamin D3 Levels With Premature Greying Of Hairs To Reveal Promising Targets For Future Interventions. 
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