| CTRI Number |
CTRI/2020/07/026794 [Registered on: 25/07/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Vitamin-D levels in COVID-19 Patients and their relationship with other bone metabolism markers |
|
Scientific Title of Study
|
Correlation of Vitamin-D levels with markers of Bone Metabolism in COVID-19 Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 181 R4 |
Protocol Number |
| AIIMSRPR/IEC/2020/553 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok Chandra Agrawal |
| Designation |
Professor of Orthopaedics |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Orthopaedics
Room No. 10, Orthopaedic OPD , D 1 Block Gate no. 4 , All India Institute of Medical Sciences, Tatibandh Raipur CG 492099
Department of Orthopaedics
Room No. 10, Orthopaedic OPD , D 1 Block Gate no. 4 , All India Institute of Medical Sciences, Tatibandh Raipur CG 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9425151634 |
| Fax |
|
| Email |
dralokcagrawal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alok Chandra Agrawal |
| Designation |
Professor of Orthopaedics |
| Affiliation |
AIIMS Raipur |
| Address |
Room no 10 , Department of orthopaedics , Orthopaedic OPD , D1 Block, Gate no 4 , AIIMS RAIPUR 492099
Tatibandh, G E Road Raipur 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9425151634 |
| Fax |
|
| Email |
dralokcagrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alok Chandra Agrawal |
| Designation |
Professor of Orthopaedics |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Orthopaedics , Room no 10, Orthopaedic OPD , D1 Block , Gate no 4, AIIMS RAIPUR
Tatibandh, G E Road Raipur 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9425151634 |
| Fax |
|
| Email |
dralokcagrawal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Grant of RS 3 LAKHS 90 THOUSAND from ,All India Institute of Medical Sciences Raipur CG India |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
Tatibandh, G E Road Raipur , India 492099 |
| Type of Sponsor |
Other [Autonomous body under Department of Health and Family Welfare, PMSSY scheme India] |
|
|
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 Alok Chandra Agrawal |
AIIMS Raipur |
Room no 10 , Department of Orthopaedics, Orthopaedic OPD , D1 Block Gate no 4 Tatibandh , G E Road, Raipur 492099 India
Raipur
CHHATTISGARH |
9425151634
dralokcagrawal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Consecutive patientsPatients giving voluntary consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
Non COVID 19 Patients
Patients not admitted in COVID 19 ward Patients not giving a consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Does Bone metabolism as judged by serum Calcium, phosphorous, alkaline phosphatase and serum Vitamin D levels get altered in COVID 19 patients? |
at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypovitaminosis D in COVID 19 patients in India |
6 months duration of sample collection on 100 COVID 19 positive patients |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/08/2020 |
| 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="20"
Months="2"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vitamin D has been found to affect the outcome of a patient with COVID 19 affection. It has been found that low levels of serum Vitamin D levels in a patient with COVID 19 symptoms has a poor outcome. This study is planned to find out the incidence of serum Vitamin D deficiency in COVID 19 patients and its relation with markers of bone metabolism. |