Abstract: PRevention of COVID-19 with Oral Vitamin D
supplemental Therapy in Essential healthCare
Teams (PROTECT): Ancillary study of a randomised
controlled trial
Banafsheh Hosseini ( banafsheh.hosseini@umontreal.ca )
University of Montreal: Universite de Montreal
Cecile L Tremblay
University of Montreal: Universite de Montreal
Cristina Longo
University of Montreal: Universite de Montreal
Shirin Golchi
McGill University
John White
McGill University
Caroline Quach
University of Montreal: Universite de Montreal
Louis-Georges Ste-Marie
University of Montreal: Universite de Montreal
Robert Platt
McGill University
Francine Ducharme
University of Montreal: Universite de Montreal https://orcid.org/0000-0001-5096-0614
Research Article
Keywords: Vitamin D, Hybrid study, Healthcare workers, Randomized controlled trial
Posted Date: July 19th, 2022
DOI: https://doi.org/10.21203/rs.3.rs-1588325/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License.
Read Full License
Page 1/20
Abstract
Background
The study objectives were to ascertain the efficacy of vitamin D supplementation in rapidly increasing
serum vitamin D and of implementation of a hybrid (virtual and in-person) trial.
Methods
In a randomised triple-blind controlled trial, healthcare workers were allocated to receive an oral bolus of
100,000 IU with 10,000 IU/week vitamin D 3 or placebo. The co-primary outcomes of this ancillary study
were the change from baseline in serum 25-hydroxyvitamin D [(Δ) 25(OH)D] and proportion with vitamin
D sufficiency (25(OH)D ≥ 75nmol/L), at endpoint. Adherence to supplements and procedures as well as
adverse event rates were documented.
Results
Thirty-four (19 intervention, 15 control) subjects were randomised, with 28 (41%) virtual visits. After 44.78
± 11.00 days from baseline, a significant adjusted group difference of 44.2 (34.7, 53.8) nmol/L was
observed in the Δ 25(OH)D (95%CI) in favor of supplementation; 77.8% of intervention, and 13.3% of
control, patients were vitamin D sufficient (OR:6.11, 95%CI:1.6, 22.9). The adherence to intervention was
94.7% in the intervention and 100% in the control groups. Irrespective of visit type, high adherence was
observed in sampling procedures and completion of fortnightly online questionnaire. No adverse events
attributable to vitamin D were reported.
Conclusion
The vitamin D supplementation rapidly and safely raised 25(OH)D levels to sufficient levels for a
biological effect. Similarly high adherence to study procedures was observed with virtual and in-person
participation.
Trial registration:
This trial was registered at https://clinicaltrials.gov on July 23, 2020 (#NCT04483635)
Background
The global pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been
regarded as the largest public health problem in recent decades1. Concurrent with the development of
Page 2/20
COVID-19 vaccines, vitamin D supplementation emerged as a potential primary prevention approach to
reduce the incidence and severity of SARS-CoV-2 infection. Indeed, a meta-analysis of 27 observational
studies showed a higher odds of COVID-19 related hospitalisation and mortality in subjects with vitamin
D deficiency than their counterparts2. Several mechanisms support the potential benefits of vitamin D for
COVID-19, particularly via its immunomodulatory effects that enhance antiviral immune response and
anti-inflammatory properties3. A reduced risk of several infections (such as..
{ 'institution': [{'name': 'Research Square'}],
'indexed': {'date-parts': [[2022, 7, 19]], 'date-time': '2022-07-19T17:42:32Z', 'timestamp': 1658252552082},
'posted': {'date-parts': [[2022, 7, 19]]},
'group-title': 'In Review',
'reference-count': 0,
'publisher': 'Research Square Platform LLC',
'license': [ { 'start': { 'date-parts': [[2022, 7, 19]],
'date-time': '2022-07-19T00:00:00Z',
'timestamp': 1658188800000},
'content-version': 'unspecified',
'delay-in-days': 0,
'URL': 'https://creativecommons.org/licenses/by/4.0/'}],
'content-domain': {'domain': [], 'crossmark-restriction': False},
'accepted': {'date-parts': [[2022, 4, 23]]},
'abstract': '<jats:title>Abstract</jats:title>\n'
' <jats:p>Background\n'
' The study objectives were to ascertain the efficacy of vitamin D supplementation in rapidly '
'increasing serum vitamin D and of implementation of a hybrid (virtual and in-person) trial.\n'
'Methods\n'
' In a randomised triple-blind controlled trial, healthcare workers were allocated to receive '
'an oral bolus of 100,000 IU with 10,000 IU/week vitamin D<jats:sub>3</jats:sub> or placebo. '
'The co-primary outcomes of this ancillary study were the change from baseline in serum '
'25-hydroxyvitamin D [(Δ) 25(OH)D] and proportion with vitamin D sufficiency (25(OH)D\u2009'
'≥\u200975nmol/L), at endpoint. Adherence to supplements and procedures as well as adverse '
'event rates were documented.\n'
'Results\n'
' Thirty-four (19 intervention, 15 control) subjects were randomised, with 28 (41%) virtual '
'visits. After 44.78\u2009±\u200911.00 days from baseline, a significant adjusted group '
'difference of 44.2 (34.7, 53.8) nmol/L was observed in the Δ 25(OH)D (95%CI) in favor of '
'supplementation; 77.8% of intervention, and 13.3% of control, patients were vitamin D '
'sufficient (OR:6.11, 95%CI:1.6, 22.9<jats:italic>).</jats:italic> The adherence to '
'intervention was 94.7% in the intervention and 100% in the control groups. Irrespective of '
'visit type, high adherence was observed in sampling procedures and completion of fortnightly '
'online questionnaire. No adverse events attributable to vitamin D were reported.\n'
'Conclusion\n'
' The vitamin D supplementation rapidly and safely raised 25(OH)D levels to sufficient levels '
'for a biological effect. Similarly high adherence to study procedures was observed with '
'virtual and in-person participation.\n'
'Trial registration:\n'
' This trial was registered at https://clinicaltrials.gov on July 23, 2020 '
'(#NCT04483635)</jats:p>',
'DOI': '10.21203/rs.3.rs-1588325/v1',
'type': 'posted-content',
'created': {'date-parts': [[2022, 7, 19]], 'date-time': '2022-07-19T17:20:13Z', 'timestamp': 1658251213000},
'source': 'Crossref',
'is-referenced-by-count': 0,
'title': 'PRevention of COVID-19 with Oral Vitamin D supplemental Therapy in Essential healthCare Teams '
'(PROTECT): Ancillary study of a randomised controlled trial',
'prefix': '10.21203',
'author': [ { 'given': 'Banafsheh',
'family': 'Hosseini',
'sequence': 'first',
'affiliation': [{'name': 'University of Montreal: Universite de Montreal'}]},
{ 'given': 'Cecile L',
'family': 'Tremblay',
'sequence': 'additional',
'affiliation': [{'name': 'University of Montreal: Universite de Montreal'}]},
{ 'given': 'Cristina',
'family': 'Longo',
'sequence': 'additional',
'affiliation': [{'name': 'University of Montreal: Universite de Montreal'}]},
{ 'given': 'Shirin',
'family': 'Golchi',
'sequence': 'additional',
'affiliation': [{'name': 'McGill University'}]},
{ 'given': 'John',
'family': 'White',
'sequence': 'additional',
'affiliation': [{'name': 'McGill University'}]},
{ 'given': 'Caroline',
'family': 'Quach',
'sequence': 'additional',
'affiliation': [{'name': 'University of Montreal: Universite de Montreal'}]},
{ 'given': 'Louis-Georges',
'family': 'Ste-Marie',
'sequence': 'additional',
'affiliation': [{'name': 'University of Montreal: Universite de Montreal'}]},
{ 'given': 'Robert',
'family': 'Platt',
'sequence': 'additional',
'affiliation': [{'name': 'McGill University'}]},
{ 'ORCID': 'http://orcid.org/0000-0001-5096-0614',
'authenticated-orcid': False,
'given': 'Francine',
'family': 'Ducharme',
'sequence': 'additional',
'affiliation': [{'name': 'University of Montreal: Universite de Montreal'}]}],
'member': '8761',
'container-title': [],
'original-title': [],
'link': [ { 'URL': 'https://www.researchsquare.com/article/rs-1588325/v1',
'content-type': 'text/html',
'content-version': 'vor',
'intended-application': 'text-mining'},
{ 'URL': 'https://www.researchsquare.com/article/rs-1588325/v1.html',
'content-type': 'unspecified',
'content-version': 'vor',
'intended-application': 'similarity-checking'}],
'deposited': { 'date-parts': [[2022, 7, 19]],
'date-time': '2022-07-19T17:20:13Z',
'timestamp': 1658251213000},
'score': 1,
'resource': {'primary': {'URL': 'https://www.researchsquare.com/article/rs-1588325/v1'}},
'subtitle': [],
'short-title': [],
'issued': {'date-parts': [[2022, 7, 19]]},
'references-count': 0,
'URL': 'http://dx.doi.org/10.21203/rs.3.rs-1588325/v1',
'relation': {},
'published': {'date-parts': [[2022, 7, 19]]},
'subtype': 'preprint'}
