| CTRI Number |
CTRI/2024/03/063420 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to explore the association between deficiency of Vitamin D in different chronic pain conditions |
|
Scientific Title of Study
|
A single-centric, retrospective non-inferiority study to explore the association between deficiency of Vitamin D in different chronic pain conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunaina Mahapatra |
| Designation |
Fellow resident |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09438404392 |
| Fax |
|
| Email |
drsunaina91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Das |
| Designation |
Director |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09163357246 |
| Fax |
|
| Email |
gdas2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Das |
| Designation |
Director |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09163357246 |
| Fax |
|
| Email |
gdas2310@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Pin-700156 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sunaina Mahapatra |
Daradia the pain clinic |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
pin-700156
Kolkata
WEST BENGAL |
09438404392
drsunaina91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DARADIA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who had visited our pain clinic from 2021-2023 for any kind of chronic pain will be included in our study |
|
| ExclusionCriteria |
| Details |
Patients already being treated for hypovitaminosis D will be excluded from our study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalance of Vit D deficiency in chronic pain conditions
|
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Demographic parameters of patients & its association with Vit D deficiency.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
15/03/2024 |
| 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="2"
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
|
Studies showing the correlation between VIT D deficiency and Chronic pain state are inconclusive. But various studies have also shown a positive correlation indicating the role of VIT D in the treatment of chronic pain conditions. so here we wanted to find out the relation of VIT D deficiency and chronic pain conditions from the patients who visited who visited our pain clinic. |