Can Vitamin D Reduce the Burden of COVID-19?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,093
- 试验地点
- 1
- 主要终点
- Time from randomization to first participant-reported COVID-19 infection
研究概览
简要总结
The purpose of this study is to compare the risks of COVID-19 in individuals from the Chicagoland area and other communities in the United States randomized to low (400 IU/day) versus moderate (4,000 IU/day) dose vitamin D.
详细描述
This study will recruit 2,000 subjects from the Chicagoland area and across the United States to participate in the study from home. Subjects will be invited to volunteer to participate in the study through a variety of forms of outreach, mainly online (e.g., press releases, news interviews, social media, emails, etc.). The sample size was chosen to have at least 80% power to detect a 20% or larger decrease in the hazard of developing COVID-19 between study arms at p<0.05, based on an estimated monthly incidence of COVID-19 (3%/month for Black/Latinx persons and 1%/month for White persons) and an estimated fraction of persons already immune but unaware they have had COVID-19 (≤10%).
Subjects will take a daily dose of vitamin D and answer surveys about COVID-19 diagnosis and symptoms over 12 months after enrollment.
Our overall aim is to compare the risks of COVID-19 in adults at increased risk of COVID-19 randomized to low (400 IU/day) versus moderate (4,000 IU/day) dose vitamin D. Our specific aims are:
Aim 1: To compare the risk of developing COVID-19 in adults at increased risk of COVID-19 randomized to low versus moderate dose vitamin D. We hypothesize that moderate 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.
Aim 2: To compare COVID-19 outcomes (symptoms, hospitalization, ICU stay, ventilator use, death) in adults at increased risk of COVID-19 randomized to low vs. moderate dose vitamin D. Consistent with several recent observational analyses, we expect higher doses to improve COVID-19 outcomes.
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 in the United States.
- •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 12-month study period.
- •Are willing to complete self-report measures at 5 time points over the course of 12 months by completing a 15-minute survey at intake via web and 10-minute web-based follow-up surveys.
排除标准
- •Subjects are excluded from study participation if they:
- •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.
研究组 & 干预措施
Low Dose Vitamin D (400 IU/day)
Subjects in this arm will be randomized to receive low dose vitamin D (oral, 400 IU/day) for 12 continuous months
干预措施: Vitamin D 400IU (Dietary Supplement)
Moderate Dose Vitamin D (4000 IU/day)
Subjects in this arm will be randomized to receive moderate dose vitamin D (oral, 4000 IU/day) for 12 continuous months
干预措施: Vitamin D 4000IU (Dietary Supplement)
结局指标
主要结局
Time from randomization to first participant-reported COVID-19 infection
时间窗: From date of randomization to the earliest of either the first participant-reported COVID-19 infection up to and including 365 days after randomization or right censoring up to 365 days after randomization
Reported in a post-randomization survey
次要结局
未报告次要终点