Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT04868903
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04868903
Study Brief:
Protocol Section:
NCT04868903