| CTRI Number |
CTRI/2021/02/030946 [Registered on: 02/02/2021] Trial Registered Prospectively |
| Last Modified On: |
01/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of Vitamin B12 with blood clotting in COVID-19 patients |
|
Scientific Title of Study
|
A study of correlation between Vitamin B12 levels and D-dimer levels - in COVID-19 positive patients at our hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karmay H Shah |
| Designation |
Post Graduate Student |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
OPD 28, GCS Medical College, Hospital and Research Centre, Opposite DRM Office, Naroda Road, Ahmedabad
Room 303, G2 block, GCS HOSTEL,Opp DRM Office, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
07966048028 |
| Fax |
|
| Email |
karmay.shah@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rushi Patel |
| Designation |
Associate Professor |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
OPD 28, GCS Medical College, Hospital and Research Centre, Opposite DRM Office, Naroda Road, Ahmedabad
GCS Medical College, Hospital and Research Centre, Opposite DRM Office, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
07966048028 |
| Fax |
|
| Email |
Rrpatel9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karmay H Shah |
| Designation |
Post Graduate Student |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
OPD 28, GCS Medical College, Hospital and Research Centre, Opposite DRM Office, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
07966048028 |
| Fax |
|
| Email |
karmay.shah@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| GCS Medical College Hospital and Research Centre,
Opp DRM office, Naroda road, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
GCS Medical College Hospital and Research Centre |
| Address |
GCS Medical College, Hospital and Research Centre, Opposite DRM Office, Naroda Road, Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Karmay Shah |
GCS Medical College, Hospital and Research Centre |
OPD room number 28,
Opposite DRM Office, Beside Chamunda bridge, Naroda Road
Ahmadabad
GUJARAT |
07966048028
karmay.shah@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GCS Medical College, Hospital and Research Centre |
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
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients who are COVID-19 positive by either COVID-19 RTPCR test or COVID-19 rapid antigen test or HRCT chest suggestive of active COVID-19 infection (CORADS III AND ABOVE)
2.All genders
3.Age above 18 years
4.Patients willing to give consent for this study
|
|
| ExclusionCriteria |
| Details |
1.Patients who are COVID-19 negative
2.Patients who have taken Vitamin B12 supplements
3.Patients who might have raised D-Dimer due to other known causes; e.g. heart disease, prolonged bed rest, post surgical, etc
4.Pregnant and lactating women
5.Age <18 years
6.Patients not willing to give consent for this study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To measure baseline Vitamin B12 levels in COVID19 positive patients
2.To measure baseline D Dimer levels in these patients
3.To measure maximum D Dimer levels in these patients through the course of hospital stay
4.To analyse following in the study population:
Duration of hospital stay
Need for oxygen support
Need for anticoagulation
Clinical outcome(recovered/expired)
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare thrombotic events in persons with Vitamin B12 deficiency and in those with normal levels |
2 months |
|
|
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)
|
17/02/2021 |
| 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="0"
Months="2"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
Aims- To compare Vitamin B12 levels and D-dimer levels of COVID 19 positive patientsTo establish, if any, correlation between Vitamin B12 deficiency and increased thrombosis (by means of D-Dimer) in the study population |