Vitamin D and COVID-19 Trial

Summary

Participation Requirements

Description

Data from laboratory studies, epidemiologic research, and randomized clinical trials conducted in the pre-COVID era strongly suggest that vitamin D is active in pathways relevant to immune function and may reduce the risk of acute respiratory infections. More recently, some observational studies hav...

Data from laboratory studies, epidemiologic research, and randomized clinical trials conducted in the pre-COVID era strongly suggest that vitamin D is active in pathways relevant to immune function and may reduce the risk of acute respiratory infections. More recently, some observational studies have shown a significant association between low vitamin D status and worse clinical outcomes among COVID-19 patients. Whether vitamin D supplementation can reduce the risk of adverse clinical outcomes in recently diagnosed COVID-19 patients and/or reduce risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) in those likely to have been exposed to the virus (post-exposure prophylaxis) is unknown. The Vitamin D and COVID-19 Trial (VIVID) is a nationwide, pragmatic, cluster-randomized clinical trial in 2700 U.S. men and women investigating whether taking a daily dietary supplement of vitamin D3 for 4 weeks reduces the rate of seeking healthcare visits (including hospitalizations, emergency room visits, or ambulatory or virtual clinician visits) for symptoms or concerns related to COVID-19 or deaths in people newly diagnosed with COVID-19, and reduces the risk of SARS-CoV-2 infection and/or disease severity in household contacts of individuals newly diagnosed with COVID-19. The trial will enroll 1500 individuals aged 18 or older who are newly diagnosed with COVID-19 ("index cases") and 1200 household contacts aged 18 or older. Following receipt of informed consent, participants will be randomized -- i.e., assigned by chance (like a coin toss) -- to one of two groups: (1) daily vitamin D3 (9600 IU/day on days 1-2; 3200 IU/day on days 3-28) or (2) daily vitamin D placebo. Index cases and household contacts of an index case (limited to at most one contact per household), if any, will be assigned to the same group (cluster randomization). Participants will take three oral softgel capsules on day 1, three capsules on day 2, and one capsule each day on days 3 through 28. Participants will receive a 4-week supply of study capsules via overnight courier service. Participants will fill out a short (15-20 minute) questionnaire each week during the 4-week pill-taking period, as well as a follow-up questionnaire at 8 weeks after randomization. These questionnaires ask about symptoms, general health, and use of medications and dietary supplements. Questionnaires will be completed online using a secure Internet-based system known as the Research Electronic Data Capture (REDCap) system. Participants must have an e-mail address to enroll in the study. Occasionally, participants (or their delegates) may receive a telephone call from study staff to collect information or to clarify answers on the questionnaire. Participants will be able to contact investigators or staff using a toll-free number, if they have any questions or need assistance. Participants (or their delegates) who indicate on a study questionnaire that they have been hospitalized will be sent a medical release form to be signed and returned. The release form will be used to get medical records from the participant's physician or hospital to confirm the specific reason for the hospitalization. In the event of a participant's death, the participant's delegate will be sent a medical release form to be signed and returned. The release form will be used to get medical records from the participant's physician or hospital to confirm the specific cause of death. Participants will provide dried blood spot samples at baseline and week 4. Participants will provide these samples using a sample collection kit mailed to their homes. Blood samples will be collected through a finger prick onto a filter paper. Blood samples will be stored and used to measure vitamin D (25(OH)D) levels. In participants who are not diagnosed with COVID-19 during the study, blood samples will be also be tested for COVID-19 antibodies. Support for VIVID is provided by Harvard University and private philanthropy. Tishcon Corporation (Salisbury, Maryland, USA) is donating the study capsules. The Karolinska Institute (Stockholm, Sweden) is donating the serology assessment, and Quest Diagnostics (San Juan Capistrano, California, USA) is donating biomarker measurements.

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