The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design.
Contemp Clin Trials
; 100: 106176, 2021 01.
Article
in English
| MEDLINE | ID: covidwho-849022
ABSTRACT
OBJECTIVES:
To determine the effect of vitamin D supplementation on disease progression and post-exposure prophylaxis for COVID-19 infection. We hypothesize that high-dose vitamin D3 supplementation will reduce risk of hospitalization/death among those with recently diagnosed COVID-19 infection and will reduce risk of COVID-19 infection among their close household contacts.METHODS:
We report the rationale and design of a planned pragmatic, cluster randomized, double-blinded trial (N = 2700 in total nationwide), with 1500 newly diagnosed individuals with COVID-19 infection, together with up to one close household contact each (~1200 contacts), randomized to either vitamin D3 (loading dose, then 3200 IU/day) or placebo in a 11 ratio and a household cluster design. The study duration is 4 weeks. The primary outcome for newly diagnosed individuals is the occurrence of hospitalization and/or mortality. Key secondary outcomes include symptom severity scores among cases and changes in the infection (seroconversion) status for their close household contacts. Changes in vitamin D 25(OH)D levels will be assessed and their relation to study outcomes will be explored.CONCLUSIONS:
The proposed pragmatic trial will allow parallel testing of vitamin D3 supplementation for early treatment and post-exposure prophylaxis of COVID-19. The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Vitamin D
/
Dietary Supplements
/
COVID-19 Drug Treatment
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Traditional medicine
Limits:
Adult
/
Humans
/
Middle aged
Language:
English
Journal:
Contemp Clin Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2021
Document Type:
Article
Similar
MEDLINE
...
LILACS
LIS