| CTRI Number |
CTRI/2021/02/031230 [Registered on: 11/02/2021] Trial Registered Prospectively |
| Last Modified On: |
10/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Estimation of vitamin D levels in covid 19 positive patients. |
|
Scientific Title of Study
|
A correlational study between vitamin D levels in covid 19 positive patients in GCS hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Tewari |
| Designation |
resident |
| Affiliation |
Gcs Medical College and research centre |
| Address |
Opd no 28,Respiratory medicine department,GCS hospital,opp DRM office ,near chamunda bridge, Ahmedabad.
Ahmadabad
GUJARAT
380025
India |
| Phone |
07966048028 |
| Fax |
|
| Email |
tewari.shraddha23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rushi R Patel |
| Designation |
Associate professor |
| Affiliation |
Gcs Medical College and research centre |
| Address |
Opd no 28,gcs hospital,opp DRM office ,near chamunda bridge, Ahmedabad.
Ahmadabad
GUJARAT
380025
India |
| Phone |
07966048028 |
| Fax |
|
| Email |
rrpatel9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shraddha Tewari |
| Designation |
resident |
| Affiliation |
Gcs Medical College and research centre |
| Address |
Opd no 28, Respiratory medicine department,GCS hospital,opp DRM office ,near chamunda bridge, Ahmedabad.
Ahmadabad
GUJARAT
380025
India |
| Phone |
07966048028 |
| Fax |
|
| Email |
tewari.shraddha23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gcs medical hospital,opp DRM office,near chamunda bridge, Ahmedabad,380025 |
|
|
Primary Sponsor
|
| Name |
Gcs medical hospital |
| Address |
Gcs medical college and research centre,opp DRM office ,near chamunda bridge,ahmedabad,380025 |
| 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 |
| Shraddha Tewari |
Gcs hospital |
Opd no 28, Respiratory medicine department,Gcs hospital and research centre,opp DRM office,near chamunda bridge, Ahmedabad,380025
Ahmadabad
GUJARAT |
07966048028
tewari.shraddha23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,gcs medical 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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are covid 19 positive either by covid19 rtpcr or rapid antigen or hrct positive.
Patients who are willing to give consent.
Above 18 years of age. |
|
| ExclusionCriteria |
| Details |
Patients who are covid 19 negative.
Patients not willing to give consent.
Patients below 18 years of age.
Pregnant and lactating women.
Patients who have taken vitamin d supplements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vitamin D levels affecting morbidity and mortality in covid 19 positive patients |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitamin d levels in covid 19 positive patients affecting duration of stay in hospital |
1 month |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2021 |
| 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="1"
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
|
This study is aimed to explore role of vitamin D levels in covid 19 positive patients and whether its baseline value has any relation to clinical presentation and outcome of the patients. |