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| Column | Value |
|---|---|
| Trial registration number | NCT04868903 |
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Full text link
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : May 11, 2023, 8 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 11, 2023, 8 a.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
2021-05-03 |
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Recruitment status
Last imported at : May 11, 2023, 8 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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. |
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Exclusion criteria
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
University of Chicago |
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Inclusion age min
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
2000 |
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primary outcome
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
SARS-CoV-2 infection as measured by patient report of clinically confirmed COVID-19 (or viral PCR when available) |
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Notes
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : May 5, 2021, 11:25 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "400 IU/day", "treatment_id": 1371, "treatment_name": "Vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "4,000 IU/day", "treatment_id": 1371, "treatment_name": "Vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "10,000 IU/day", "treatment_id": 1371, "treatment_name": "Vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}] |