Low vs. Moderate to High Dose Vitamin D for Prevention of COVID-19 (NCT04868903) | Clinical Trial Compass
CompletedNot Applicable
Low vs. Moderate to High Dose Vitamin D for Prevention of COVID-19
United States1,475 participantsStarted 2020-11-30
Plain-language 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 vitamin D.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. R…
What they're measuring
1
SARS-CoV-2 Infection as Measured by Patient Report of Clinically Confirmed COVID-19 (or Viral PCR When Available)