Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S)
efficacy of therapeutic cholecalciferol supplementation for severe COVID-19 is sparingly studied. effect of single high-dose cholecalciferol supplementation on sequential organ failure assessment (SOFA) score in moderate-to-severe COVID-19. participants with moderate to severe COVID-19 with PaO2/FiO...
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| Veröffentlicht in: | Journal of public health (Oxford, England) England), 2024-05, Vol.46 (2), p.256-266 |
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| creator | Singh, Ajay Rastogi, Ashu Puri, Goverdhan Dutt Ganesh, Venkata Naik, Naveen Bal Kajal, Kamal Kahlon, Shubhkarman Soni, Shiv Lal Kaloria, Narender Saini, Kulbhushan Hazarika, Amarjyoti Mahajan, Varun Singla, Karan Bhadada, Sanjay Soni, Vaishali |
| description | efficacy of therapeutic cholecalciferol supplementation for severe COVID-19 is sparingly studied.
effect of single high-dose cholecalciferol supplementation on sequential organ failure assessment (SOFA) score in moderate-to-severe COVID-19.
participants with moderate to severe COVID-19 with PaO2/FiO2 ratio 50 ng/ml is safe and reduces sequential organ failure assessment score, in-hospital mortality in moderate to severe COVID-19. How this study might affect research, practice or policy-vitamin D supplementation in vitamin D-deficient patients with severe COVID-19 is useful may be practiced. |
| doi_str_mv | 10.1093/pubmed/fdae007 |
| format | Article |
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effect of single high-dose cholecalciferol supplementation on sequential organ failure assessment (SOFA) score in moderate-to-severe COVID-19.
participants with moderate to severe COVID-19 with PaO2/FiO2 ratio < 200 were randomized to 0.6 million IU cholecalciferol oral (intervention) or placebo.
primary outcome was change in Day 7 SOFA score and pre-specified secondary outcomes were SOFA and 28-day all-cause mortality.
in all, 90 patients (45 each group) were included for intention-to-treat analysis. 25(OH)D3 levels were 12 (10-16) and 13 (12-18) ng/ml (P = 0.06) at baseline; and 60 (55-65) ng/ml and 4 (1-7) ng/ml by Day 7 in vitamin D and placebo groups, respectively. The SOFA score on Day 7 was better in the vitamin D group [3 (95% CI, 2-5) versus 5 (95% CI, 3-7), P = 0.01, intergroup difference - 2 (95% CI, -4 to -0.01); r = 0.4]. A lower all-cause 28-day mortality [24% compared to 44% (P = 0.046)] was observed with vitamin D.
single high-dose oral cholecalciferol supplementation on ICU admission can improve SOFA score at Day 7 and reduce in-hospital mortality in vitamin D-deficient COVID-19. ClinicalTrials.gov id: NCT04952857 registered dated 7 July 2021. What is already known on this topic-vitamin D has immunomodulatory role. Observational and isolated intervention studies show some benefit in COVID-19. Targeted therapeutic vitamin D supplementation improve outcomes in severe COVID-19 is not studied in RCTs. What this study adds-high-dose vitamin D supplementation (0.6 Million IU) to increase 25(OH)D > 50 ng/ml is safe and reduces sequential organ failure assessment score, in-hospital mortality in moderate to severe COVID-19. How this study might affect research, practice or policy-vitamin D supplementation in vitamin D-deficient patients with severe COVID-19 is useful may be practiced.</description><identifier>ISSN: 1741-3842</identifier><identifier>ISSN: 1741-3850</identifier><identifier>EISSN: 1741-3850</identifier><identifier>DOI: 10.1093/pubmed/fdae007</identifier><identifier>PMID: 38291897</identifier><language>eng</language><publisher>England</publisher><subject>Adult ; Aged ; Betacoronavirus ; Cholecalciferol - administration & dosage ; Cholecalciferol - therapeutic use ; Coronavirus Infections - drug therapy ; Coronavirus Infections - mortality ; COVID-19 - complications ; COVID-19 - mortality ; COVID-19 Drug Treatment ; Dietary Supplements ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Organ Dysfunction Scores ; Pandemics ; Pneumonia, Viral - drug therapy ; Pneumonia, Viral - mortality ; SARS-CoV-2 ; Severity of Illness Index ; Treatment Outcome ; Vitamin D - blood ; Vitamin D Deficiency - complications ; Vitamin D Deficiency - drug therapy ; Vitamins - administration & dosage ; Vitamins - therapeutic use</subject><ispartof>Journal of public health (Oxford, England), 2024-05, Vol.46 (2), p.256-266</ispartof><rights>The Author(s) 2024. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c225t-ce2c81e0ad0fe5d0e0121f9c9709df61caeab1f62423377d889d245bbb94852b3</citedby><cites>FETCH-LOGICAL-c225t-ce2c81e0ad0fe5d0e0121f9c9709df61caeab1f62423377d889d245bbb94852b3</cites><orcidid>0000-0002-9375-3102 ; 0000-0003-1526-5370</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38291897$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Singh, Ajay</creatorcontrib><creatorcontrib>Rastogi, Ashu</creatorcontrib><creatorcontrib>Puri, Goverdhan Dutt</creatorcontrib><creatorcontrib>Ganesh, Venkata</creatorcontrib><creatorcontrib>Naik, Naveen Bal</creatorcontrib><creatorcontrib>Kajal, Kamal</creatorcontrib><creatorcontrib>Kahlon, Shubhkarman</creatorcontrib><creatorcontrib>Soni, Shiv Lal</creatorcontrib><creatorcontrib>Kaloria, Narender</creatorcontrib><creatorcontrib>Saini, Kulbhushan</creatorcontrib><creatorcontrib>Hazarika, Amarjyoti</creatorcontrib><creatorcontrib>Mahajan, Varun</creatorcontrib><creatorcontrib>Singla, Karan</creatorcontrib><creatorcontrib>Bhadada, Sanjay</creatorcontrib><creatorcontrib>Soni, Vaishali</creatorcontrib><title>Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S)</title><title>Journal of public health (Oxford, England)</title><addtitle>J Public Health (Oxf)</addtitle><description>efficacy of therapeutic cholecalciferol supplementation for severe COVID-19 is sparingly studied.
effect of single high-dose cholecalciferol supplementation on sequential organ failure assessment (SOFA) score in moderate-to-severe COVID-19.
participants with moderate to severe COVID-19 with PaO2/FiO2 ratio < 200 were randomized to 0.6 million IU cholecalciferol oral (intervention) or placebo.
primary outcome was change in Day 7 SOFA score and pre-specified secondary outcomes were SOFA and 28-day all-cause mortality.
in all, 90 patients (45 each group) were included for intention-to-treat analysis. 25(OH)D3 levels were 12 (10-16) and 13 (12-18) ng/ml (P = 0.06) at baseline; and 60 (55-65) ng/ml and 4 (1-7) ng/ml by Day 7 in vitamin D and placebo groups, respectively. The SOFA score on Day 7 was better in the vitamin D group [3 (95% CI, 2-5) versus 5 (95% CI, 3-7), P = 0.01, intergroup difference - 2 (95% CI, -4 to -0.01); r = 0.4]. A lower all-cause 28-day mortality [24% compared to 44% (P = 0.046)] was observed with vitamin D.
single high-dose oral cholecalciferol supplementation on ICU admission can improve SOFA score at Day 7 and reduce in-hospital mortality in vitamin D-deficient COVID-19. ClinicalTrials.gov id: NCT04952857 registered dated 7 July 2021. What is already known on this topic-vitamin D has immunomodulatory role. Observational and isolated intervention studies show some benefit in COVID-19. Targeted therapeutic vitamin D supplementation improve outcomes in severe COVID-19 is not studied in RCTs. What this study adds-high-dose vitamin D supplementation (0.6 Million IU) to increase 25(OH)D > 50 ng/ml is safe and reduces sequential organ failure assessment score, in-hospital mortality in moderate to severe COVID-19. How this study might affect research, practice or policy-vitamin D supplementation in vitamin D-deficient patients with severe COVID-19 is useful may be practiced.</description><subject>Adult</subject><subject>Aged</subject><subject>Betacoronavirus</subject><subject>Cholecalciferol - administration & dosage</subject><subject>Cholecalciferol - therapeutic use</subject><subject>Coronavirus Infections - drug therapy</subject><subject>Coronavirus Infections - mortality</subject><subject>COVID-19 - complications</subject><subject>COVID-19 - mortality</subject><subject>COVID-19 Drug Treatment</subject><subject>Dietary Supplements</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Organ Dysfunction Scores</subject><subject>Pandemics</subject><subject>Pneumonia, Viral - drug therapy</subject><subject>Pneumonia, Viral - mortality</subject><subject>SARS-CoV-2</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><subject>Vitamin D - blood</subject><subject>Vitamin D Deficiency - complications</subject><subject>Vitamin D Deficiency - drug therapy</subject><subject>Vitamins - administration & dosage</subject><subject>Vitamins - therapeutic use</subject><issn>1741-3842</issn><issn>1741-3850</issn><issn>1741-3850</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkUlPwzAQhS0EgrJcOSIfi4Spl4TE3FDLJiFxKHCNvIypURIHO0GC_8B_ptACp5k3-uYd3kPokNFTRqWYdINuwE6cVUBpsYFGrMgYEWVON__2jO-g3ZReKOWS03wb7YiSS1bKYoQ-HxYQVQdD7w1e-OcFsSEBfvO9anyLZ9iF-K-IBeeNh7bHCd4gAp7eP93OCJPY-gQqwTmOqrWh8R9gT7ANg66B6Nq3S9XVyoAOxIS2j6GuweLUD_Ydj-c3F7NLMj_eR1tO1QkO1nMPPV5dPkxvyN399e304o4YzvOeGOCmZECVpQ5yS4Eyzpw0sqDSujNmFCjN3BnPuBBFYctSWp7lWmuZlTnXYg-NV75dDK8DpL5qfDJQ16qFMKTqJ6dCUCqW6OkKNTGkFMFVXfSNiu8Vo9V3BdWqgmpdwfLhaO29uv_iv5mLL0vrhMY</recordid><startdate>20240529</startdate><enddate>20240529</enddate><creator>Singh, Ajay</creator><creator>Rastogi, Ashu</creator><creator>Puri, Goverdhan Dutt</creator><creator>Ganesh, Venkata</creator><creator>Naik, Naveen Bal</creator><creator>Kajal, Kamal</creator><creator>Kahlon, Shubhkarman</creator><creator>Soni, Shiv Lal</creator><creator>Kaloria, Narender</creator><creator>Saini, Kulbhushan</creator><creator>Hazarika, Amarjyoti</creator><creator>Mahajan, Varun</creator><creator>Singla, Karan</creator><creator>Bhadada, Sanjay</creator><creator>Soni, Vaishali</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9375-3102</orcidid><orcidid>https://orcid.org/0000-0003-1526-5370</orcidid></search><sort><creationdate>20240529</creationdate><title>Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S)</title><author>Singh, Ajay ; Rastogi, Ashu ; Puri, Goverdhan Dutt ; Ganesh, Venkata ; Naik, Naveen Bal ; Kajal, Kamal ; Kahlon, Shubhkarman ; Soni, Shiv Lal ; Kaloria, Narender ; Saini, Kulbhushan ; Hazarika, Amarjyoti ; Mahajan, Varun ; Singla, Karan ; Bhadada, Sanjay ; Soni, Vaishali</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c225t-ce2c81e0ad0fe5d0e0121f9c9709df61caeab1f62423377d889d245bbb94852b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Betacoronavirus</topic><topic>Cholecalciferol - administration & dosage</topic><topic>Cholecalciferol - therapeutic use</topic><topic>Coronavirus Infections - drug therapy</topic><topic>Coronavirus Infections - mortality</topic><topic>COVID-19 - complications</topic><topic>COVID-19 - mortality</topic><topic>COVID-19 Drug Treatment</topic><topic>Dietary Supplements</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Organ Dysfunction Scores</topic><topic>Pandemics</topic><topic>Pneumonia, Viral - drug therapy</topic><topic>Pneumonia, Viral - mortality</topic><topic>SARS-CoV-2</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><topic>Vitamin D - blood</topic><topic>Vitamin D Deficiency - complications</topic><topic>Vitamin D Deficiency - drug therapy</topic><topic>Vitamins - administration & dosage</topic><topic>Vitamins - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Singh, Ajay</creatorcontrib><creatorcontrib>Rastogi, Ashu</creatorcontrib><creatorcontrib>Puri, Goverdhan Dutt</creatorcontrib><creatorcontrib>Ganesh, Venkata</creatorcontrib><creatorcontrib>Naik, Naveen Bal</creatorcontrib><creatorcontrib>Kajal, Kamal</creatorcontrib><creatorcontrib>Kahlon, Shubhkarman</creatorcontrib><creatorcontrib>Soni, Shiv Lal</creatorcontrib><creatorcontrib>Kaloria, Narender</creatorcontrib><creatorcontrib>Saini, Kulbhushan</creatorcontrib><creatorcontrib>Hazarika, Amarjyoti</creatorcontrib><creatorcontrib>Mahajan, Varun</creatorcontrib><creatorcontrib>Singla, Karan</creatorcontrib><creatorcontrib>Bhadada, Sanjay</creatorcontrib><creatorcontrib>Soni, Vaishali</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of public health (Oxford, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Singh, Ajay</au><au>Rastogi, Ashu</au><au>Puri, Goverdhan Dutt</au><au>Ganesh, Venkata</au><au>Naik, Naveen Bal</au><au>Kajal, Kamal</au><au>Kahlon, Shubhkarman</au><au>Soni, Shiv Lal</au><au>Kaloria, Narender</au><au>Saini, Kulbhushan</au><au>Hazarika, Amarjyoti</au><au>Mahajan, Varun</au><au>Singla, Karan</au><au>Bhadada, Sanjay</au><au>Soni, Vaishali</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S)</atitle><jtitle>Journal of public health (Oxford, England)</jtitle><addtitle>J Public Health (Oxf)</addtitle><date>2024-05-29</date><risdate>2024</risdate><volume>46</volume><issue>2</issue><spage>256</spage><epage>266</epage><pages>256-266</pages><issn>1741-3842</issn><issn>1741-3850</issn><eissn>1741-3850</eissn><abstract>efficacy of therapeutic cholecalciferol supplementation for severe COVID-19 is sparingly studied.
effect of single high-dose cholecalciferol supplementation on sequential organ failure assessment (SOFA) score in moderate-to-severe COVID-19.
participants with moderate to severe COVID-19 with PaO2/FiO2 ratio < 200 were randomized to 0.6 million IU cholecalciferol oral (intervention) or placebo.
primary outcome was change in Day 7 SOFA score and pre-specified secondary outcomes were SOFA and 28-day all-cause mortality.
in all, 90 patients (45 each group) were included for intention-to-treat analysis. 25(OH)D3 levels were 12 (10-16) and 13 (12-18) ng/ml (P = 0.06) at baseline; and 60 (55-65) ng/ml and 4 (1-7) ng/ml by Day 7 in vitamin D and placebo groups, respectively. The SOFA score on Day 7 was better in the vitamin D group [3 (95% CI, 2-5) versus 5 (95% CI, 3-7), P = 0.01, intergroup difference - 2 (95% CI, -4 to -0.01); r = 0.4]. A lower all-cause 28-day mortality [24% compared to 44% (P = 0.046)] was observed with vitamin D.
single high-dose oral cholecalciferol supplementation on ICU admission can improve SOFA score at Day 7 and reduce in-hospital mortality in vitamin D-deficient COVID-19. ClinicalTrials.gov id: NCT04952857 registered dated 7 July 2021. What is already known on this topic-vitamin D has immunomodulatory role. Observational and isolated intervention studies show some benefit in COVID-19. Targeted therapeutic vitamin D supplementation improve outcomes in severe COVID-19 is not studied in RCTs. What this study adds-high-dose vitamin D supplementation (0.6 Million IU) to increase 25(OH)D > 50 ng/ml is safe and reduces sequential organ failure assessment score, in-hospital mortality in moderate to severe COVID-19. How this study might affect research, practice or policy-vitamin D supplementation in vitamin D-deficient patients with severe COVID-19 is useful may be practiced.</abstract><cop>England</cop><pmid>38291897</pmid><doi>10.1093/pubmed/fdae007</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-9375-3102</orcidid><orcidid>https://orcid.org/0000-0003-1526-5370</orcidid></addata></record> |
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| identifier | ISSN: 1741-3842 |
| ispartof | Journal of public health (Oxford, England), 2024-05, Vol.46 (2), p.256-266 |
| issn | 1741-3842 1741-3850 1741-3850 |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE |
| subjects | Adult Aged Betacoronavirus Cholecalciferol - administration & dosage Cholecalciferol - therapeutic use Coronavirus Infections - drug therapy Coronavirus Infections - mortality COVID-19 - complications COVID-19 - mortality COVID-19 Drug Treatment Dietary Supplements Double-Blind Method Female Humans Male Middle Aged Organ Dysfunction Scores Pandemics Pneumonia, Viral - drug therapy Pneumonia, Viral - mortality SARS-CoV-2 Severity of Illness Index Treatment Outcome Vitamin D - blood Vitamin D Deficiency - complications Vitamin D Deficiency - drug therapy Vitamins - administration & dosage Vitamins - therapeutic use |
| title | Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S) |
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