| CTRI Number |
CTRI/2025/07/090200 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An investigation to find the relationship between level of testosterone, vitamin D in blood and bone mineral density in men with chronic spinal cord injury after a trauma . |
|
Scientific Title of Study
|
An observational study for association of 25 (OH) vitamin D, testosterone levels and their correlation with bone mineral density in men with chronic traumatic spinal cord injury. |
| 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 Khhyati Jain |
| Designation |
Resident doctor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
PMR Department , RRC Building, Gate No. 3, SMS Medical College Jaipur, Rajasthan
PMR Department , RRC Building , Gate No. 3, RRC Building, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8949046093 |
| Fax |
|
| Email |
khhyati94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khhyati Jain |
| Designation |
Resident doctor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
PMR Department, RRC Building, Gate No.3 , SMS Medical College Jaipur, Rajasthan
PMR Department, RRC Building, Gate No.3 , Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8949046093 |
| Fax |
|
| Email |
khhyati94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khhyati Jain |
| Designation |
Resident doctor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
PMR Department, RRC Building, Gate No. 3, SMS Medical College Jaipur, Rajasthan
PMR Department, RRC Building, Gate No. 3, SMS Medical College Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8949046093 |
| Fax |
|
| Email |
khhyati94@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College, Jaipur, Rajasthan India Pin 302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College Jaipur |
| Address |
PMR Department , RRC Building, SMS Medical College, Jaipur , 302004 , Rajasthan , India |
| Type of Sponsor |
Government 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 Sunil Goenka |
SMS Medical College Jaipur |
PMR Department, RRC Building Gate No.3 , SMS Medical College, Jaipur
Jaipur
RAJASTHAN |
9314969696
dr_goenka@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee, S.M.S. Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients who are willing to give informed written consent.
2. Men who suffered traumatic spinal cord injury three months ago.
3. Men aged between 18 to 60 years. |
|
| ExclusionCriteria |
| Details |
1. Patients who have taken vitamin D and testosterone supplements after spinal cord injury.
2. Any medical or surgical condition affecting the bone metabolism.
3. Non cooperative and cognitive impaired patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum vitamin D
Serum testosterone |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| T score of lumbar spine, hip joint, wrist joint |
Baseline |
|
|
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)
|
16/07/2025 |
| 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 - NO
|
|
Brief Summary
|
By investigating the potential association between vitamin D and testosterone levels in patients with chronic spinal cord injury, this study aims to contribute to our understanding of the complex hormonal dysregulation that often accompanies this condition. Ultimately, a deeper understanding of this association may pave the way for improved management strategies, enhanced quality of life and better overall health outcomes for patients with chronic spinal cord injury. |