Status:
TERMINATED
PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Laboratoire RIVA
Conditions:
COVID-19
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
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-dos...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04483635
Start Date
February 8 2021
End Date
May 25 2021
Last Update
May 28 2021
Active Locations (2)
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1
CHUM
Montreal, Quebec, Canada, H2W 1T8
2
CHU Sainte-Justine (CHUSJ)
Montreal, Quebec, Canada, H3T1C5