A SARS-CoV-2 Infection clinical trial begins in United States

The research company University of Chicago is conducting the clinical trial Low vs. Moderate to High Dose Vitamin D for Prevention of COVID-19.

The purpose of this study is to compare the risks of COVID-19 in individuals from Chicagoland communities randomized to low (400 IU/day) vs. moderate (4,000 IU/day) or high (10,000 IU/day) dose vitamin D.

It is planned to include 2000 participants.

Actual study start date is November 30, 2020. The researchers expect to complete the study by December 30, 2022.

One primary outcome measure is SARS-CoV-2 infection as measured by patient report of clinically confirmed COVID-19 (or viral PCR when available), For this outcome, hazard models will be employed to assess the effect of each vitamin D dosing strategy on the outcome. 

Subjects are able to participate if they:

1. Are 18 years or older.

2. Live or work in the Chicagloland area (Illinois counties: Cook, Lake, McHenry, DuPage, Kane, Kendall, Grundy, Will, and Kankakee; Indiana counties: Lake and Porter).

3. Are interested in vitamin D as a potential preventive measure against COVID-19 in which they self-administer a daily dose of vitamin D during the 9-month study period.

4. Are willing to attend the laboratory for drop-in appointments at UChicago Medicine or Rush University Medical Center every 3 months at 4 time points over a 9-month period for blood draws measuring COVID-19 antibodies, calcium, vitamin D and PTH levels.

5. Are willing to complete self-report measures at 4 time points over the course of 9 months by completing a 15-minute survey at intake by telephone or via web and 10-minute web-based follow-up surveys.

For exclusion criteria and further details please visit: https://ichgcp.net/clinical-trials-registry/NCT04868903.

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