Low vs. Moderate to High Dose Vitamin D for Prevention of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,475
- 试验地点
- 2
- 主要终点
- SARS-CoV-2 Infection as Measured by Patient Report of Clinically Confirmed COVID-19 (or Viral PCR When Available)
研究概览
简要总结
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.
详细描述
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 to participate in the study through a variety of forms of community outreach (flyers, presentations, emails, etc.). The sample size was chosen to have at least 80% power to detect a 25% or larger decrease in the hazard of developing COVID-19 between study arms at p<0.05 assuming a 30% baseline COVID-19 incidence rate over the study period, in line with a 3% per month incidence.
Subjects will take a daily dose of vitamin D, attend laboratory appointments for testing, and answer surveys over 9 months after enrollment.
Our overall aim is to compare the risks of COVID-19 in adults in the Chicagoland area at increased risk of COVID-19 randomized to low (400 IU/day) vs. moderate (4,000 IU/day) or high (10,000 IU/day) dose vitamin D. Our specific aims are:
Aim 1: To compare the risk of developing COVID-19 in adults in the Chicagoland area at increased risk of COVID-19 randomized to low vs. moderate or high dose vitamin D. Subjects will specify their preference for moderate versus high dose vitamin D and then be randomized between low dose vitamin D and their preferred moderate or high dose alternative. We hypothesize that moderate and high dose therapy will reduce rates of COVID-19 compared to low dose therapy because vitamin D will reduce symptomatic infection that prompts testing for COVID-19. Our primary analysis will pool subjects randomized to the moderate or high dose and compare them to low dose subjects, with secondary analyses comparing low to moderate and low to high.
Aim 2: To compare COVID-19 seroconversion in adults in the Chicagoland area at increased risk of COVID-19 randomized to low vs. moderate or high dose vitamin D. As we suspect the main effect of vitamin D may be to decrease symptomatic disease we hypothesize that there may be little or no difference in seroconversion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 D
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Vitamin D3 (Dietary Supplement)
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.
干预措施: Vitamin D3 (Dietary Supplement)
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.
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
SARS-CoV-2 Infection as Measured by Patient Report of Clinically Confirmed COVID-19 (or Viral PCR When Available)
时间窗: Up to 9-months
For this outcome, hazard models will be employed to assess the effect of each vitamin D dosing strategy on the outcome. We will first develop hazard ratios for between-group analyses on the primary outcome using log-rank tests, and then develop Cox proportional hazard models to model the hazard function on a set of covariates including but not limited to, moderate or high vitamin D dose, baseline vitamin D levels, age, gender, race, ethnicity, sun exposure, sleep habits, exposure of cohabitants, job type, and study site. We will also control for randomization date to adjust the underlying hazard function for COVID-19 prevalence over time. While our primary analysis will pool subjects randomized to either the moderate or high dose and compare them to low dose subjects, we will also perform secondary analyses comparing low to moderate and low to high and additional analyses that use post randomization vitamin D levels as time varying covariates.
SARS-CoV-2 Infection as Measured by Patient Report of Clinically Confirmed COVID-19 (or Viral PCR When Available)
时间窗: Up to 9-months
For this outcome, hazard models will be employed to assess the effect of each vitamin D dosing strategy on the outcome. We will first develop hazard ratios for between-group analyses on the primary outcome using log-rank tests, and then develop Cox proportional hazard models to model the hazard function on a set of covariates including but not limited to, moderate or high vitamin D dose, baseline vitamin D levels, age, gender, race, ethnicity, sun exposure, sleep habits, exposure of cohabitants, job type, and study site. We will also control for randomization date to adjust the underlying hazard function for COVID-19 prevalence over time. While our primary analysis will pool subjects randomized to either the moderate or high dose and compare them to low dose subjects, we will also perform secondary analyses comparing low to moderate and low to high and additional analyses that use post randomization vitamin D levels as time varying covariates.
次要结局
未报告次要终点