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COVID-19Phase 3PROTECTNCT04483635

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

A Phase 3 study testing Vitamin D in people with COVID-19, run by St. Justine's Hospital at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 69 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
2 sitesCanada
Study dates
8 Feb 2021to 25 May 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • CHUM

    Montreal, Quebec, H2W 1T8

  • CHU Sainte-Justine (CHUSJ)

    Montreal, Quebec, H3T1C5

Other trials in Canada

About this study

Official title: PROTECT RCT (PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams

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.

Read the 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
Being tested
Placebo, Vitamin D
Keywords
Vitamin D, Primary prevention, Health care workers
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Weekly oral dose of placebo

  • Vitamin DDietary supplement

    Also called cholecalciferol

    Weekly oral dose of Vitamin D

Study groups in NCT04483635
Study groupRoleWhat they receive
PlaceboPlacebo comparator10 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.
Receives: Dietary Supplement: Placebo
Vitamin D3Experimental10 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.
Receives: Dietary Supplement: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 16 weeks

Secondary outcomes (6)

  1. Distribution of disease severity

    5-category ordinal variable [asymptomatic, mild (managed at home); moderate (hospitalisation without supplemental oxygen; severe (oxygen supplementation); critical (mechanical ventilation/death)

    Measured: up to 16 weeks

  2. Duration of symptoms in COVID-19 positive participants

    For asymptomatic positive COVID-19 participants, symptoms will be recorded in a daily diary up to 14 days. Symptomatic positive COVID-19 participants will record their symptoms in a daily diary up to 48 hours after the resolution of symptoms

    Measured: up to 16 weeks

  3. Number of participants with COVID-19 positive IgG serology

    SARS-CoV-2 IgG Diasorin on Liaison XL platform

    Measured: 16 weeks

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

    Participant-reported; reported by Direction of Human Resource (or for physicians, Direction des services professionnelles) databases

    Measured: 16 weeks

  5. Number of workday absences for any reason

    Participant-reported; reported by Direction of Human Resource (or for physicians, Direction des services professionnelles) databases

    Measured: 16 weeks

  6. Adverse health events

    Number and distribution of adverse health events

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start8 Feb 2021
  3. Primary completion4 May 2021
  4. Study completion25 May 2021

Why it stopped: A premature discontinuation was recommended by the Data Safety Monitoring Board and agreed upon by the principal investigator, because the significantly lower recruitment than planned, in the context of mass vaccination of the target population.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-group, placebo controlled trial of vitamin D3 supplementation
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04483635
Sponsor's protocol ID
MP-21-2021-3044
Acronym
PROTECT
Status last verified
May 2021
First submitted
29 Jun 2020
Last updated
28 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37230524

  • 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.

    PubMed 36527143

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin D in people with COVID-19, run by St. Justine's Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: A premature discontinuation was recommended by the Data Safety Monitoring Board and agreed upon by the principal investigator, because the significantly lower recruitment than planned, in the context of mass vaccination of the target population.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in incidence of laboratory-confirmed COVID-19 infection (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04483635, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.

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