Baseline Vitamin D Deficiency and COVID-19 Disease Severity

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ClinicalTrials.gov Identifier: NCT04628000

Recruitment Status : Recruiting

First Posted : November 13, 2020

Last Update Posted : November 16, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Doug Duffee, Parkview Medical Center

Study Description

Brief Summary:

It is known that vitamin D has been found to decrease incidence of viral respiratory infections, as well as have effects on multiple cytokines involved in immunomodulation and the bradykinin/renin-angiotensin system.

Recently, data was released showing a correlation between baseline vitamin D deficiency status and increased risk of contracting COVID-19.

Separate analysis shows that many of the deleterious effects of COVID-19 may be due to the bradykinin/RAS system, and that vitamin D is one plausible treatment option to modulate these effects.

Studies are currently ongoing to determine if vitamin D supplementation of those hospitalized with COVID-19 has a beneficial effect on patient outcomes.

Healthcare resources have been strained during the pandemic in areas of heavy caseload. It is possible that those with concurrent vitamin D deficiency and COVID positivity have an increased need for escalation of care. A small study has been conducted in this area, but was limited by small number of subjects.

Condition or disease	Intervention/treatment
Vitamin D Deficiency Covid19	Other: Vitamin D

Detailed Description:

Abstract: It is known that vitamin D has been found to decrease incidence of viral respiratory infections, as well as have effects on multiple cytokines involved in immunomodulation and the bradykinin/renin-angiotensin system. Recently, data was released showing a correlation between baseline vitamin D deficiency status and increased risk of contracting COVID-19. Separate analysis shows that many of the deleterious effects of COVID-19 may be due to the bradykinin/RAS system, and that vitamin D is one plausible treatment option to modulate these effects. Studies are currently ongoing to determine if vitamin D supplementation of those hospitalized with COVID-19 has a beneficial effect on patient outcomes.

Objective: To determine if those hospitalized with COVID-19 with baseline vitamin D deficiency, have worse outcomes during their stay than those who are not vitamin D deficient at baseline.

Design, Setting, and Participants: This is a retrospective cohort study at an urban academic medical center which included patients with a 25-hydroxycholecalciferol level measured within one year before being tested for COVID-19 and hospitalized from March 9th to September 7th, 2020.

Exposures: Vitamin D deficiency was defined by the last measurement of 25-hydroxycholecalciferol less than 20 ng/mL before COVID testing (within one year).

Main Outcomes and Measures: The primary outcomes investigated include length of stay, need for supplemental oxygen, ICU admission, need for invasive life support (mechanical ventilation, vasopressors, dialysis), and discharge status (discharged alive vs. death).

Study Design

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Study Type :	Observational
Estimated Enrollment :	50 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Baseline Vitamin D Deficiency and COVID-19 Disease Severity/Need for Escalation of Care
Actual Study Start Date :	October 27, 2020
Estimated Primary Completion Date :	October 14, 2021
Estimated Study Completion Date :	April 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) Vitamin D Vitamin D Deficiency

Drug Information available for: Vitamin D

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Vitamin D deficiency and COVID19 Vitamin D deficiency and COVID19	Other: Vitamin D Clinical Correlation Other Name: Vitamin D deficiency

Outcome Measures

Primary Outcome Measures :

LOS duration in days [ Time Frame: 3/9-9/7 2020 ]
Length of stay
Supp O2 flow volume in L/min [ Time Frame: 3/9-9/7 2020 ]
Supplemental Oxygen need

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 100 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Non-Probability Sample

Study Population

Those hospitalized 3/9-9/7 2020 who were covid positive and had concomitant vit d level drawn

Criteria

Inclusion Criteria:

Covid 19 +
Vitamin D level

Exclusion Criteria:

Age < 18
no associated vitamin D level

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628000

Contacts

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Contact: Stephaine Lucas, MD	719-595-8456 ext 8456	stephanie_lucas@parkviewmc.com
Contact: Doug Duffee, MD	719-595-7968 ext 7968	douglas_duffee@parkviewmc.com

Locations

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United States, Colorado
Parkview Medical Center	Recruiting
Pueblo, Colorado, United States, 81003
Contact: Doug Duffee, MD 719-595-7968 douglas_duffee@parkviewmc.com

Sponsors and Collaborators

Parkview Medical Center

Investigators

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Principal Investigator:	Stephanie Lucas, MD	Parkview Medical Center

More Information

Publications:

Martineau AR, Jolliffe DA, Greenberg L, Aloia JF, Bergman P, Dubnov-Raz G, Esposito S, Ganmaa D, Ginde AA, Goodall EC, Grant CC, Janssens W, Jensen ME, Kerley CP, Laaksi I, Manaseki-Holland S, Mauger D, Murdoch DR, Neale R, Rees JR, Simpson S, Stelmach I, Trilok Kumar G, Urashima M, Camargo CA, Griffiths CJ, Hooper RL. Vitamin D supplementation to prevent acute respiratory infections: individual participant data meta-analysis. Health Technol Assess. 2019 Jan;23(2):1-44. doi: 10.3310/hta23020.

Grant WB, Lahore H, McDonnell SL, Baggerly CA, French CB, Aliano JL, Bhattoa HP. Evidence that Vitamin D Supplementation Could Reduce Risk of Influenza and COVID-19 Infections and Deaths. Nutrients. 2020 Apr 2;12(4). pii: E988. doi: 10.3390/nu12040988. Review.

Garvin MR, Alvarez C, Miller JI, Prates ET, Walker AM, Amos BK, Mast AE, Justice A, Aronow B, Jacobson D. A mechanistic model and therapeutic interventions for COVID-19 involving a RAS-mediated bradykinin storm. Elife. 2020 Jul 7;9. pii: e59177. doi: 10.7554/eLife.59177.

ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2020 Apr 10 - . Identifier NCT04334005, Vitamin D on Prevention and Treatment of COVID 19 (COVITD-19) [cited 2020 Sept 9]; Available from: https://clinicaltrials.gov/ct2/show/NCT04334005

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Responsible Party:	Doug Duffee, Research Committee Chair, Parkview Medical Center
ClinicalTrials.gov Identifier:	NCT04628000
Other Study ID Numbers:	PIRB78
First Posted:	November 13, 2020 Key Record Dates
Last Update Posted:	November 16, 2020
Last Verified:	November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Doug Duffee, Parkview Medical Center:


prognosis

Additional relevant MeSH terms:

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COVID-19 Vitamin D Deficiency Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases	Respiratory Tract Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Ergocalciferols Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents

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