Condition category
Infections and Infestations
Date applied
29/05/2020
Date assigned
01/06/2020
Last edited
02/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The COVID-19 pandemic which began in late 2019 has raged across the globe with more than 4 million infections and 300,000 deaths recorded to date. A broad theme of immune overreaction has emerged as a key determinant of disease severity and patient outcome. Intuitively, immunomodulation becomes an attractive potential treatment strategy. Besides lung involvement, COVID-19 is a multi-organ phenomenon and appropriate systemic inflammatory control is necessary for overall survival benefit. Much of the current treatment effort is targeted at viral elimination instead of modulating immune overreaction. A number of immunomodulatory agents may be helpful including vitamin D, magnesium and vitamin B12. Importantly, these compounds are generally safe and well-tolerated by patients. A short course of these three supplements (DMB) could potentially exert synergistic effects to improve COVID-19 severity. This study aims to determine the usefulness of combination of vitamin D, magnesium and vitamin B12 in older COVID-19 patients.

Who can participate?
COVID-19-positive patients aged 50 and over

What does the study involve?
Patients will be given a combination of vitamin D, magnesium and vitamin B12, up to 14 days. The risk of clinical deterioration (requirement for supplemental oxygen and/or intensive care support) is measured using patient records from the hospital information system at day 30.

What are the possible benefits and risks of participating?
If proven to be effective, DMB could reduce the severity of COVID-19 in older patients. There is minimal risk since these supplements are generally safe and well-tolerated by patients.

Where is the study run from?
Singapore General Hospital (Singapore)

When is the study starting and how long is it expected to run for?
March 2020 to May 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Liam Pock Ho
gpthlp@sgh.com.sg

Trial website

Contact information

Type

Scientific

Primary contact

Dr L Ho

ORCID ID

http://orcid.org/0000-0001-5146-7565

Contact details

Department of Clinical Pathology
Level 7
Academia
20 College Road
Singapore
169856
Singapore
+65 (0)63214626
gpthlp@sgh.com.sg

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CIRB 2020/2344

Study information

Scientific title

A cohort study to evaluate the effect of combination vitamin D, magnesium and vitamin B12 (DMB) on progression to severe outcome in older COVID-19 patients

Acronym

DMB

Study hypothesis

Does administering a combination of vitamin D, magnesium and vitamin B12 (DMB) to older COVID-19 patients reduce the severity of their infection?

Ethics approval

Approved 19/05/2020, SingHealth institutional ethics committee (Singapore Health Services Pte Ltd, 31 Third Hospital Avenue, #03-03 Bowyer Block C, Singapore, 168753; +65(0) 6225 0488; irb@singhealth.com.sg), ref: 2020/2344

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

Therapy comprised a single daily oral dose of vitamin D3 1000 IU, magnesium 150 mg and vitamin B12 500 mcg for up to 14 days, with follow-up to Day 30 from onset of symptoms.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

The risk of clinical deterioration, defined as the requirement for supplemental oxygen and/or intensive care support, measured using patient records from hospital information system at day 30

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

02/03/2020

Overall trial end date

15/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All consecutive COVID-19-positive patients aged 50 years and above admitted to Singapore General Hospital during the study period

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

40 (20 untreated and 20 treated)

Total final enrolment

43

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

06/04/2020

Recruitment end date

15/04/2020

Locations

Countries of recruitment

Singapore

Trial participating centre

Singapore General Hospital
Outram Road
Singapore
169608
Singapore

Sponsor information

Organisation

SingHealth

Sponsor details

31 Third Hospital Avenue
#03-03 Bowyer Block C
Singapore
168753
Singapore
+65 (0)63237515
irb@singhealth.com.sg

Sponsor type

Hospital/treatment centre

Website

https://www.singhealth.com.sg/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

In the midst of preparation.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/10/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/06/2020: Internal review. 01/06/2020: Trial's existence confirmed by SingHealth institutional ethics committee.