Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)

Jolliffe, David A; Holt, Hayley; Greenig, Matthew; Talaei, Mohammad; Perdek, Natalia; Pfeffer, Paul; Vivaldi, Giulia; Maltby, Sheena; Symons, Jane; Barlow, Nicola L; Normandale, Alexa; Garcha, Rajvinder; Richter, Alex G; Faustini, Sian E; Orton, Chris; Ford, David; Lyons, Ronan; Davies, Gwyneth; Kee, Frank; Griffiths, Christopher J; Norrie, John; Sheikh, Aziz; Shaheen, Seif O; Relton, Clare; Martineau, Adrian R

doi:10.1136/bmj-2022-071230

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Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)

David A Jolliffe

, Hayley Holt, Matthew Greenig, Mohammad Talaei

, Natalia Perdek, Paul Pfeffer

, Giulia Vivaldi

, Sheena Maltby, Jane Symons

, Nicola L Barlow, Alexa Normandale, Rajvinder Garcha, Alex G Richter

, Sian E Faustini

, Chris Orton

, David Ford

, Ronan Lyons

, Gwyneth Davies

, Frank Kee

, Christopher J Griffiths, John Norrie, Aziz Sheikh

, Seif O Shaheen

, Clare Relton, Adrian R Martineau

BMJ, Start page: e071230

Swansea University Authors: Chris Orton , David Ford , Ronan Lyons , Gwyneth Davies

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DOI (Published version): 10.1136/bmj-2022-071230

Abstract

Objective To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19.Design Phase 3 open label randomised contro...

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Published in:	BMJ
ISSN:	1756-1833
Published:	BMJ 2022
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa61819

first_indexed	2022-11-28T12:38:30Z
last_indexed	2023-01-13T19:22:50Z
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fullrecord	<?xml version="1.0"?><rfc1807><datestamp>2022-12-22T13:09:59.7847469</datestamp><bib-version>v2</bib-version><id>61819</id><entry>2022-11-08</entry><title>Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)</title><swanseaauthors><author><sid>555c622e1f7bd9d2e0341f2ebbfd3e7f</sid><ORCID>0000-0002-9561-2493</ORCID><firstname>Chris</firstname><surname>Orton</surname><name>Chris Orton</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>52fc0c473b0da1b7218d87f9fc68a3e6</sid><ORCID>0000-0001-6551-721X</ORCID><firstname>David</firstname><surname>Ford</surname><name>David Ford</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>83efcf2a9dfcf8b55586999d3d152ac6</sid><ORCID>0000-0001-5225-000X</ORCID><firstname>Ronan</firstname><surname>Lyons</surname><name>Ronan Lyons</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>92d69cf8519a334ced3f55142c811d95</sid><ORCID>0000-0003-1218-1008</ORCID><firstname>Gwyneth</firstname><surname>Davies</surname><name>Gwyneth Davies</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2022-11-08</date><deptcode>MEDS</deptcode><abstract>Objective To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19.Design Phase 3 open label randomised controlled trial.Setting United Kingdom.Participants 6200 people aged ≥16 years who were not taking vitamin D supplements at baseline.Interventions Offer of a postal finger prick test of blood 25(OH)D concentration with provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, compared with no offer of testing or supplementation (n=3100). Follow-up was for six months.Main outcome measures The primary outcome was the proportion of participants with at least one swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary outcome was the proportion of participants with swab test confirmed covid-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. The primary analysis was conducted by intention to treat.Results Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and 2674 (86.3%) had 25(OH)D concentrations <75 nmol/L and received vitamin D supplements (n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 (5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and 76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group (1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to 1.63).Conclusions Among people aged 16 years and older with a high baseline prevalence of suboptimal vitamin D status, implementation of a population level test-and-treat approach to vitamin D supplementation was not associated with a reduction in risk of all cause acute respiratory tract infection or covid-19.</abstract><type>Journal Article</type><journal>BMJ</journal><volume>0</volume><journalNumber/><paginationStart>e071230</paginationStart><paginationEnd/><publisher>BMJ</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>1756-1833</issnElectronic><keywords/><publishedDay>7</publishedDay><publishedMonth>9</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-09-07</publishedDate><doi>10.1136/bmj-2022-071230</doi><url>https://pubmed.ncbi.nlm.nih.gov/36215226/</url><notes>Clinical Trial</notes><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>This study was supported by Barts Charity (refs MGU0459 and MGU0466), Pharma Nord, the Fischer Family Foundation, DSM Nutritional Products, the Exilarch’s Foundation, the Karl R Pfleger Foundation, the AIM Foundation, Synergy Biologics, Cytoplan, the UK National Institute for Health and Care Research Clinical Research Network (refs 52255 and 52257), the HDR UK BREATHE Hub, the UK Research and Innovation Industrial Strategy Challenge Fund (ref MC_PC_19004), Thornton & Ross, Warburtons, Hyphens Pharma, and a personal donation from Matthew Isaacs (a philanthropist without financial interests constituting a potential conflict). MT was supported by a grant from the Rosetrees Trust and The Bloom Foundation (ref M771) until May 2021 and has been supported by the Barts Charity since then (ref MGU0570).</funders><projectreference/><lastEdited>2022-12-22T13:09:59.7847469</lastEdited><Created>2022-11-08T12:57:05.0954087</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>David A</firstname><surname>Jolliffe</surname><orcid>0000-0003-3592-1945</orcid><order>1</order></author><author><firstname>Hayley</firstname><surname>Holt</surname><order>2</order></author><author><firstname>Matthew</firstname><surname>Greenig</surname><order>3</order></author><author><firstname>Mohammad</firstname><surname>Talaei</surname><orcid>0000-0002-6901-3665</orcid><order>4</order></author><author><firstname>Natalia</firstname><surname>Perdek</surname><order>5</order></author><author><firstname>Paul</firstname><surname>Pfeffer</surname><orcid>0000-0003-0369-2885</orcid><order>6</order></author><author><firstname>Giulia</firstname><surname>Vivaldi</surname><orcid>0000-0003-0816-9276</orcid><order>7</order></author><author><firstname>Sheena</firstname><surname>Maltby</surname><order>8</order></author><author><firstname>Jane</firstname><surname>Symons</surname><orcid>0000-0003-2535-4545</orcid><order>9</order></author><author><firstname>Nicola L</firstname><surname>Barlow</surname><order>10</order></author><author><firstname>Alexa</firstname><surname>Normandale</surname><order>11</order></author><author><firstname>Rajvinder</firstname><surname>Garcha</surname><order>12</order></author><author><firstname>Alex G</firstname><surname>Richter</surname><orcid>0000-0003-2885-1299</orcid><order>13</order></author><author><firstname>Sian E</firstname><surname>Faustini</surname><orcid>0000-0002-9300-5569</orcid><order>14</order></author><author><firstname>Chris</firstname><surname>Orton</surname><orcid>0000-0002-9561-2493</orcid><order>15</order></author><author><firstname>David</firstname><surname>Ford</surname><orcid>0000-0001-6551-721X</orcid><order>16</order></author><author><firstname>Ronan</firstname><surname>Lyons</surname><orcid>0000-0001-5225-000X</orcid><order>17</order></author><author><firstname>Gwyneth</firstname><surname>Davies</surname><orcid>0000-0003-1218-1008</orcid><order>18</order></author><author><firstname>Frank</firstname><surname>Kee</surname><orcid>0000-0002-0606-8167</orcid><order>19</order></author><author><firstname>Christopher J</firstname><surname>Griffiths</surname><order>20</order></author><author><firstname>John</firstname><surname>Norrie</surname><order>21</order></author><author><firstname>Aziz</firstname><surname>Sheikh</surname><orcid>0000-0001-7022-3056</orcid><order>22</order></author><author><firstname>Seif O</firstname><surname>Shaheen</surname><orcid>0000-0002-7273-8691</orcid><order>23</order></author><author><firstname>Clare</firstname><surname>Relton</surname><order>24</order></author><author><firstname>Adrian R</firstname><surname>Martineau</surname><orcid>0000-0001-5387-1721</orcid><order>25</order></author></authors><documents><document><filename>61819__25930__e147095bcff443c49f37818a0b09c85e.pdf</filename><originalFilename>61819.pdf</originalFilename><uploaded>2022-11-28T12:38:55.6533815</uploaded><type>Output</type><contentLength>673874</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://creativecommons.org/licenses/by-nc/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling	2022-12-22T13:09:59.7847469 v2 61819 2022-11-08 Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT) 555c622e1f7bd9d2e0341f2ebbfd3e7f 0000-0002-9561-2493 Chris Orton Chris Orton true false 52fc0c473b0da1b7218d87f9fc68a3e6 0000-0001-6551-721X David Ford David Ford true false 83efcf2a9dfcf8b55586999d3d152ac6 0000-0001-5225-000X Ronan Lyons Ronan Lyons true false 92d69cf8519a334ced3f55142c811d95 0000-0003-1218-1008 Gwyneth Davies Gwyneth Davies true false 2022-11-08 MEDS Objective To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19.Design Phase 3 open label randomised controlled trial.Setting United Kingdom.Participants 6200 people aged ≥16 years who were not taking vitamin D supplements at baseline.Interventions Offer of a postal finger prick test of blood 25(OH)D concentration with provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, compared with no offer of testing or supplementation (n=3100). Follow-up was for six months.Main outcome measures The primary outcome was the proportion of participants with at least one swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary outcome was the proportion of participants with swab test confirmed covid-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. The primary analysis was conducted by intention to treat.Results Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and 2674 (86.3%) had 25(OH)D concentrations <75 nmol/L and received vitamin D supplements (n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 (5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and 76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group (1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to 1.63).Conclusions Among people aged 16 years and older with a high baseline prevalence of suboptimal vitamin D status, implementation of a population level test-and-treat approach to vitamin D supplementation was not associated with a reduction in risk of all cause acute respiratory tract infection or covid-19. Journal Article BMJ 0 e071230 BMJ 1756-1833 7 9 2022 2022-09-07 10.1136/bmj-2022-071230 https://pubmed.ncbi.nlm.nih.gov/36215226/ Clinical Trial COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University This study was supported by Barts Charity (refs MGU0459 and MGU0466), Pharma Nord, the Fischer Family Foundation, DSM Nutritional Products, the Exilarch’s Foundation, the Karl R Pfleger Foundation, the AIM Foundation, Synergy Biologics, Cytoplan, the UK National Institute for Health and Care Research Clinical Research Network (refs 52255 and 52257), the HDR UK BREATHE Hub, the UK Research and Innovation Industrial Strategy Challenge Fund (ref MC_PC_19004), Thornton & Ross, Warburtons, Hyphens Pharma, and a personal donation from Matthew Isaacs (a philanthropist without financial interests constituting a potential conflict). MT was supported by a grant from the Rosetrees Trust and The Bloom Foundation (ref M771) until May 2021 and has been supported by the Barts Charity since then (ref MGU0570). 2022-12-22T13:09:59.7847469 2022-11-08T12:57:05.0954087 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine David A Jolliffe 0000-0003-3592-1945 1 Hayley Holt 2 Matthew Greenig 3 Mohammad Talaei 0000-0002-6901-3665 4 Natalia Perdek 5 Paul Pfeffer 0000-0003-0369-2885 6 Giulia Vivaldi 0000-0003-0816-9276 7 Sheena Maltby 8 Jane Symons 0000-0003-2535-4545 9 Nicola L Barlow 10 Alexa Normandale 11 Rajvinder Garcha 12 Alex G Richter 0000-0003-2885-1299 13 Sian E Faustini 0000-0002-9300-5569 14 Chris Orton 0000-0002-9561-2493 15 David Ford 0000-0001-6551-721X 16 Ronan Lyons 0000-0001-5225-000X 17 Gwyneth Davies 0000-0003-1218-1008 18 Frank Kee 0000-0002-0606-8167 19 Christopher J Griffiths 20 John Norrie 21 Aziz Sheikh 0000-0001-7022-3056 22 Seif O Shaheen 0000-0002-7273-8691 23 Clare Relton 24 Adrian R Martineau 0000-0001-5387-1721 25 61819__25930__e147095bcff443c49f37818a0b09c85e.pdf 61819.pdf 2022-11-28T12:38:55.6533815 Output 673874 application/pdf Version of Record true This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license true eng http://creativecommons.org/licenses/by-nc/4.0/
title	Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)
spellingShingle	Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT) Chris Orton David Ford Ronan Lyons Gwyneth Davies
title_short	Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)
title_full	Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)
title_fullStr	Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)
title_full_unstemmed	Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)
title_sort	Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)
author_id_str_mv	555c622e1f7bd9d2e0341f2ebbfd3e7f 52fc0c473b0da1b7218d87f9fc68a3e6 83efcf2a9dfcf8b55586999d3d152ac6 92d69cf8519a334ced3f55142c811d95
author_id_fullname_str_mv	555c622e1f7bd9d2e0341f2ebbfd3e7f_*_Chris Orton 52fc0c473b0da1b7218d87f9fc68a3e6__David Ford 83efcf2a9dfcf8b55586999d3d152ac6__Ronan Lyons 92d69cf8519a334ced3f55142c811d95_*_Gwyneth Davies
author	Chris Orton David Ford Ronan Lyons Gwyneth Davies
author2	David A Jolliffe Hayley Holt Matthew Greenig Mohammad Talaei Natalia Perdek Paul Pfeffer Giulia Vivaldi Sheena Maltby Jane Symons Nicola L Barlow Alexa Normandale Rajvinder Garcha Alex G Richter Sian E Faustini Chris Orton David Ford Ronan Lyons Gwyneth Davies Frank Kee Christopher J Griffiths John Norrie Aziz Sheikh Seif O Shaheen Clare Relton Adrian R Martineau
format	Journal article
container_title	BMJ
container_volume	0
container_start_page	e071230
publishDate	2022
institution	Swansea University
issn	1756-1833
doi_str_mv	10.1136/bmj-2022-071230
publisher	BMJ
college_str	Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id	facultyofmedicinehealthandlifesciences
hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id	facultyofmedicinehealthandlifesciences
hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
url	https://pubmed.ncbi.nlm.nih.gov/36215226/
document_store_str	1
active_str	0
description	Objective To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19.Design Phase 3 open label randomised controlled trial.Setting United Kingdom.Participants 6200 people aged ≥16 years who were not taking vitamin D supplements at baseline.Interventions Offer of a postal finger prick test of blood 25(OH)D concentration with provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, compared with no offer of testing or supplementation (n=3100). Follow-up was for six months.Main outcome measures The primary outcome was the proportion of participants with at least one swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary outcome was the proportion of participants with swab test confirmed covid-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. The primary analysis was conducted by intention to treat.Results Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and 2674 (86.3%) had 25(OH)D concentrations <75 nmol/L and received vitamin D supplements (n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 (5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and 76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group (1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to 1.63).Conclusions Among people aged 16 years and older with a high baseline prevalence of suboptimal vitamin D status, implementation of a population level test-and-treat approach to vitamin D supplementation was not associated with a reduction in risk of all cause acute respiratory tract infection or covid-19.
published_date	2022-09-07T02:49:28Z
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score	11.063606

Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)

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