PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams

NCT ID: NCT04483635

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2021-05-25

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-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.

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 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.

Data analyses: An intention-to-treat analysis will be carried out on all randomized participants. Efficacy and safety analyses will be performed under allocation concealment with unblinding occurring after trial completion and analysis of primary outcomes.

Conditions

COVID-19

Keywords

Vitamin D; Primary prevention; Health care workers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Weekly oral dose of placebo

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Weekly oral dose of Vitamin D

Interventions

Placebo

Weekly oral dose of placebo

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D

Weekly oral dose of Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

cholecalciferol

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Laboratoire RIVA

UNKNOWN

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Francine Ducharme

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francine M Ducharme, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Cecile Tremblay, MD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

CHUM

Montreal, Quebec, Canada

CHU Sainte-Justine (CHUSJ)

Montreal, Quebec, Canada

Countries

Canada

References

Ducharme FM, Tremblay C, Golchi S, Hosseini B, Longo C, White JH, Coviello D, Quach C, Ste-Marie LG, Platt RW. Prevention of COVID-19 with oral vitamin D supplemental therapy in essential healthcare teams (PROTECT): protocol for a multicentre, triple-blind, randomised, placebo-controlled trial. BMJ Open. 2023 May 25;13(5):e064058. doi: 10.1136/bmjopen-2022-064058.

Reference Type: DERIVED

PMID: 37230524 (View on PubMed)

Hosseini B, Tremblay CL, Longo C, Glochi S, White JH, Quach C, Ste-Marie LG, Platt RW, Ducharme FM. Oral vitamin D supplemental therapy to attain a desired serum 25-hydroxyvitamin D concentration in essential healthcare teams. Trials. 2022 Dec 16;23(1):1019. doi: 10.1186/s13063-022-06944-z.

Reference Type: DERIVED

PMID: 36527143 (View on PubMed)

Other Identifiers

MP-21-2021-3044

Identifier Type: -

Identifier Source: org_study_id