PROTECT RCT (PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in incidence of laboratory-confirmed COVID-19 infection
研究概览
简要总结
In this 16-week randomized control study, health care workers will receive a bolus dose followed by a weekly dose of vitamin D or a placebo bolus and weekly dose. This study will test whether high-dose of vitamin D supplementation decreases the incidence of laboratory-confirmed COVID19 infection (primary outcome), reduces illness severity, duration, as well as work absenteeism among health care workers (HCW) in setting at high-risk of contact with COVID-19 cases in high COVID-19 incidence areas.
详细描述
Design. A 16-week triple-blind, placebo-controlled parallel-group, randomised trial of high-dose vitamin D supplementation compared to placebo in health care workers (HCW).
Subjects: HCW caring for individuals at high-risk of infection (i.e., COVID-suspected or confirmed cases) will be randomly allocated in a 1:1 ratio in variable block size to: Intervention-1 oral loading dose of 100,000 IU vitamin D3 + 10000 IU weekly vitamin D3 or Control-identical placebo loading dose + daily placebo. Follow-up: 2 (randomisation and end-of-study) virtual or in-person visits with weekly reminders, brief health and work-status questionnaire.
Randomisation/allocation concealment: Randomisation will be implemented using a computer-generated random list stratified by regions; health care workers will be allocated (1:1) using permuted block randomisation to enhance concealment.
Sample size: A total of 2414 healthcare workers will provide 80% power to detect a 20% reduction in the risk of laboratory-confirmed COVID-19 infection. Given uncertainties in the infection progression, a Bayesian adaptive design is used where the posterior probability of effectiveness is the basis of inference and decision making, for study continuation or termination.
Procedures. Use of remote or in-person randomisation and/or end-of-study visits and remote documentation of outcomes via electronic communication, mailing of biological samples, and external databases will facilitate enrolment, monitoring, and retention of motivated HCW in this high-intensity trial.
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)
盲法说明
The Laboratoires Riva will provide the active vitamin D3 and placebo pills, identical in appearance, which will be pre-packaged in coded 60-pill bottles. A web-based randomisation system will allow the research personnel (RP) to log in, obtain a randomization number, and dispense study drugs, pre-prepared by the Central pharmacy, in masked kits.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are aged ≥18 and <70 years old;
- •licenced to practice in Quebec;
- •working or scheduled to work over the next 16 weeks in a setting at high-risk of contact with COVID-19 infected individuals, particularly (but not only) those involved with aerosol generating medical procedures in hospitals and/or caring for patients in long-term care facilities;
- •working in high COVID incidence areas;
- •covered by the RAMQ for medical services and hospitalisations;
- •has a personal email or phone (to which to send every two weeks a reminder and questionnaire by email or text messages);
- •has a fixed address (to which to send the material) in the greater Montreal or surrounding areas.
排除标准
- •vitamin D supplementation >400 IU/day or >12,000 IU/month in past 3 months;
- •intention to take >400 IU per day during the study period;
- •suspected or previously documented COVID-19 infection;
- •history of nephrolithiasis, hypercalcemia, hyperphosphatemia, hyperparathyroidism, granulomatosis disease (e.g., tuberculosis, sarcoidosis), renal impairment/failure, or active cancer;
- •use of any of the following medications: lithium, teriparatide, or digoxin;
- •anticipated prolonged absence from work during the study period (i.e., pregnancy);
- •enrolment in a concurrent randomized trial;
- •has received a vaccine against COVID-19.
研究组 & 干预措施
Placebo
10 placebo tablets taken orally at baseline, followed by 1 placebo tablet once a week for 16 weeks
Note that the study may be prolonged according to the overall infection rate monitored monthly.
干预措施: Placebo (Dietary Supplement)
Vitamin D3
10 tablets containing 10,000 IU (total : 100,000 IU) of Vitamin D3 taken orally at baseline, followed by 10,000 IU once a week for 16 weeks.
Note that the study may be prolonged according to the overall infection rate monitored monthly.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Change in incidence of laboratory-confirmed COVID-19 infection
时间窗: 16 weeks
documented by salivary or NP samples obtained clinically for screening or diagnostic purposes throughout the study period, self-obtained salivary samples at endpoint, analysed by RT-qPCR or COVID-19 seroconversion at endpoints
次要结局
- Duration of symptoms in COVID-19 positive participants(up to 16 weeks)
- Number of workday absences due to COVID-19 suspected/confirmed infection(16 weeks)
- Distribution of disease severity(up to 16 weeks)
- Number of participants with COVID-19 positive IgG serology(16 weeks)
- Number of workday absences for any reason(16 weeks)
- Adverse health events(16 weeks)
研究者
Professor Francine Ducharme
Principal Investigator
St. Justine's Hospital