The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design
Rui Wang , Victor DeGruttola, Quanhong Lei, Kenneth H Mayer, Susan Redline, Aditi Hazra, Samia Mora, Walter C Willett, Davaasambuu Ganmaa, and JoAnn E Manson
Their objective is to evaluate how vitamin D supplementation affects illness development and COVID-19 infection post-exposure prophylaxis. High-dose vitamin D3 supplementation, we predict, will minimize the risk of hospitalization/death in those who have just been diagnosed with COVID-19 infection, as well as the risk of COVID-19 infection in their close household contacts. The trial will last for four weeks. The probability of hospitalization and/or fatality is the key outcome for newly diagnosed people. Symptom severity scores among patients and changes in the infection status of their close household contacts are important secondary outcomes. Changes in vitamin D 25(OH)D levels will be examined, as well as their relationship to research results. Parallel testing of vitamin D3 supplementation for early treatment and post-exposure prophylaxis of COVID-19 will be possible in the proposed pragmatic experiment. The home cluster design is a cost-effective method of evaluating an intervention for lowering hospitalization and/or death rates in newly diagnosed individuals, as well as avoiding infection among their close home contacts.