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.
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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
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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..
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"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.\nMethods\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 ≥ 75nmol/L), at endpoint. Adherence to supplements and procedures as well as adverse event rates were documented.\nResults\n 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<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.\nConclusion\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.\nTrial registration:\n This trial was registered at https://clinicaltrials.gov on July 23, 2020 (#NCT04483635)</jats:p>",
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