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

Status: Completed
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

‣ 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.

Locations
United States
Illinois
Rush University Medical Center
Chicago
University of Chicago
Chicago
Time Frame
Start Date: 2020-11-30
Completion Date: 2024-12-01
Participants
Target number of participants: 1475
Treatments
Active_comparator: Low Dose Vitamin D
Subjects in this arm will be randomized to receive low dose vitamin D therapy (oral, 400 IU/day) for 9 continuous months.
Active_comparator: Medium Dose Vitamin D
Subjects in this arm will be randomized to receive low dose vitamin D therapy (oral, 4,000 IU/day) for 9 continuous months.
Active_comparator: High Dose Vitamin D
Subjects in this arm will be randomized to receive low dose vitamin D therapy (oral, 10,000 IU/day) for 9 continuous months.
Sponsors
Leads: University of Chicago
Collaborators: Rush University Medical Center

This content was sourced from clinicaltrials.gov

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