Status:
COMPLETED
Low vs. Moderate to High Dose Vitamin D for Prevention of COVID-19
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Rush University Medical Center
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 vitami...
Detailed Description
This study will recruit 2,000 subjects from the Chicagoland area to participate in the study at University of Chicago Medicine (UCM) and at Rush University (RU). Subjects will be invited to volunteer ...
Eligibility Criteria
Inclusion
- Subjects are able to participate if they:
- Are 18 years or older.
- Live or work in the Chicagloland area (Illinois counties: Cook, Lake, McHenry, DuPage, Kane, Kendall, Grundy, Will, and Kankakee; Indiana counties: Lake and Porter).
- 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.
- 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.
- 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:
- Report ever having a positive COVID-19 PCR test result
- Report being pregnant, planning to become pregnant, and/or report breastfeeding during the study period.
- Report a history of chronic kidney disease, including a history of abnormal GFR and/or creatinine.
- Report a history of hyperparathyroidism.
- Report a history of increased falls.
- Report a history of hypercalcemia.
- Report a history of gastrointestinal absorptive disorders, including having undergone bariatric surgery.
- Report a history of kidney stones (1 in past year or 2 in lifetime).
- 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.
- Report taking D2.
- Report a history of sarcoidosis.
- Screen positive for hypercalcemia during the initial blood test or follow-up blood tests.
- Screen positive for primary hyperparathyroidism during the initial blood test.
- Screen positive for COVID-19 antibodies during the initial blood test.
- Have vitamin D levels of \>100ng/mL at study start, or \>250ng/mL during follow-up labs.
- Are unwilling to provide blood samples during quarterly blood tests.
- Are unwilling to take daily vitamin D.
Exclusion
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
1475 Patients enrolled
Trial Details
Trial ID
NCT04868903
Start Date
November 30 2020
End Date
December 1 2024
Last Update
December 10 2025
Active Locations (2)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
University of Chicago
Chicago, Illinois, United States, 60637-1622