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.