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

NCT04483635 | Terminated Phase 3 DMC

• 1 other identifier: MP-21-2021-3044
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

Vitamin D; Primary prevention; Health care workers

Outcome Measures

Primary Outcomes (1)

• Change in incidence of laboratory-confirmed COVID-19 infection

  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

  16 weeks

Secondary Outcomes (6)

• Distribution of disease severity

  up to 16 weeks

• Duration of symptoms in COVID-19 positive participants

  up to 16 weeks

• Number of participants with COVID-19 positive IgG serology

  16 weeks

• Number of workday absences due to COVID-19 suspected/confirmed infection

  16 weeks

• Number of workday absences for any reason

  16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Vitamin D3

EXPERIMENTAL

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.

Dietary Supplement: Vitamin D

Interventions

Placebo DIETARY_SUPPLEMENT

Weekly oral dose of placebo

Placebo

Vitamin D DIETARY_SUPPLEMENT

Weekly oral dose of Vitamin D

Also known as: cholecalciferol

Vitamin D3

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Laboratoire RIVA: collaborator

Study Sites (2)

CHUM

Montreal, Quebec, H2W 1T8, Canada

Location

CHU Sainte-Justine (CHUSJ)

Montreal, Quebec, H3T1C5, Canada

Location

Related Publications (2)

• 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.

  PMID: 37230524 DERIVED

• 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.

  PMID: 36527143 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Francine M Ducharme, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Cecile Tremblay, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel-group, placebo controlled trial of vitamin D3 supplementation

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 23, 2020
• Study Start: February 8, 2021
• Primary Completion: May 4, 2021
• Study Completion: May 25, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

CA (2)