To study the safety and efficacy of Vitamin D3, Vitamin K2-7 & magnesium , in prevention of COVID 19 infection in health care professional (HCP)

Phase 2

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/06/026191
• Lead Sponsor: Suraksha Pharma Private Limited

Brief Summary

Thisopen label study will be conducted    in  all   health care professionals ,  who are in  high risk of getting COVID- 19 , due to veryclose contact  during the managementof  COVID- 19 positive  patients.

Study protocol and other study relateddocuments will receive written approval from the ethic committee beforeinitiation of any study related activity.

Every participant will be explained aboutthe study  in detail, and allowed to askany question about study related activity  Participant who are willing toparticipate  in this present study willprovide  written consent. Participationis voluntary and one can withdraw from the study any time.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-08
• Last Update Posted: 2020-06-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 1.Participants of either sex, 20 to 60 years of age who are at high risk.
• High-risk individuals are defined as all health care professionals in hospitals, clinics, and emergency rooms, and medical facilities involved in management of COVID -19 patients.
• (Doctors, nursing staff, paramedical staff, ambulance staff, other hospital staff, ward attendees coming in contact with COVID -19 patients).
• 2.Participants who are negative for RT-PCR test for COVID-19 infection 3.Participants who are willing to provide inform consent and willing to come for schedule follow up visit.
• 4.Participant not having contra indication to take Vitamin D, 5.Participants having no COVID- 19 infection clinically.
• 6.Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study.

Exclusion Criteria

• 1Participants with known allergy or contraindication to Vitamin D ,Vitamin K2-7 & Magnesium .
• 2History of having received any investigational drug in the preceding one month.
• 3History of taking any kind of formulation or any other form of therapy for COVID- 19 prophylaxis.
• 4Unwilling to come for regular follow-up for the entire duration of the study.
• 5Any condition that, in the opinion of the investigator, does not justify the subject‘s inclusion in the study.
• 6Participants participating in other clinical study.
• 7Participant receiving other immune enhancers.
• 8Refusal to sign informed consent form 9Any previous positive test for COVID-19 by RT- PCR 10Symptomatic for COVID-19.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the safety and efficacy of Vitamin D3, Vitamin K2-7 & magnesium , in prevention of COVID 19 infection in health care professional (HCP)	Development of COVID- 19 infection in 5 weeks study period .

Secondary Outcome Measures

Name	Time	Method
1.Prevention of COVID-19 measured by negative testing with RT-PCR( In symptomatic participants ) [Time Frame 5 weeks]	2.To determine if treatment with Vitamin D can prevent COVID-19 infection [ Time Frame 5 week]

Trial Locations

Locations (1)

A C Subba Reddy Medical Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

A C Subba Reddy Medical Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr Sudarsi B

Principal investigator

9550845095

dr_sudarsi@yahoo.co.in