A study to assess the usefulness of combination of Vitamin D, magnesium and Vitamin B12 in older COVID-19 patients
| ISRCTN | ISRCTN15324611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15324611 |
| Secondary identifying numbers | CIRB 2020/2344 |
- Submission date
- 29/05/2020
- Registration date
- 01/06/2020
- Last edited
- 17/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Scientific
Department of Clinical Pathology, Level 7, Academia
20 College Road
Singapore
169856
Singapore
 ORCID ID |
0000-0001-5146-7565 |
|---|---|
| Phone | +65 (0)63214626 |
| gpthlp@sgh.com.sg |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available |
| 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 |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 02/03/2020 |
| Overall study end date | 15/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 40 (20 untreated and 20 treated) |
| Total final enrolment | 43 |
| Participant inclusion criteria | All consecutive COVID-19-positive patients aged 50 years and above admitted to Singapore General Hospital during the study period |
| 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
Study participating centre
Singapore
169608
Singapore
Sponsor information
Hospital/treatment centre
31 Third Hospital Avenue
#03-03 Bowyer Block C
Singapore
168753
Singapore
| Phone | +65 (0)63237515 |
|---|---|
| irb@singhealth.com.sg | |
| Website | https://www.singhealth.com.sg/ |
"ROR" |
https://ror.org/04me94w47 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | In the midst of preparation. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2020 | 17/03/2021 | Yes | No |
Editorial Notes
17/03/2021: Publication reference added.
02/06/2020: Internal review.
01/06/2020: Trial's existence confirmed by SingHealth institutional ethics committee.
