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Low vs. Moderate to High Dose Vitamin D for Prevention of COVID-19

CompletedNA

Sponsor: University of Chicago

Conditions: SARS-CoV-2 Infection

Interventions: Vitamin D3

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Subjects are excluded from study participation if they:

1. Report ever having a positive COVID-19 PCR test result
2. Report being pregnant, planning to become pregnant, and/or report breastfeeding during the study period.
3. Report a history of chronic kidney disease, including a history of abnormal GFR and/or creatinine.
4. Report a history of hyperparathyroidism.
5. Report a history of increased falls.
6. Report a history of hypercalcemia.
7. Report a history of gastrointestinal absorptive disorders, including having undergone bariatric surgery.
8. Report a history of kidney stones (1 in past year or 2 in lifetime).
9. Report already taking more than 400 IU of vitamin D daily as recommended by their health care provider, excluding multivitamins and excluding supplements that include vitamin D and calcium together.
10. Report taking D2.
11. Report a history of sarcoidosis.
12. Screen positive for hypercalcemia during the initial blood test or follow-up blood tests.
13. Screen positive for primary hyperparathyroidism during the initial blood test.
14. Screen positive for COVID-19 antibodies during the initial blood test.
15. Have vitamin D levels of \>100ng/mL at study start, or \>250ng/mL during follow-up labs.
16. Are unwilling to provide blood samples during quarterly blood tests.
17. Are unwilling to take daily vitamin D.

Locations (2)

Chicago, Illinois, United States
Chicago, Illinois, United States