Clinical trial NCT04628000: Baseline Vitamin D Deficiency and COVID-19 Disease Severity
Official title: Baseline Vitamin D Deficiency and COVID-19 Disease Severity/Need for Escalation of Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Covid19
Keywords: prognosis
Lead sponsor: Parkview Medical Center
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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).

Eligibility criteria: Inclusion Criteria:

* Covid 19 +
* Vitamin D level

Exclusion Criteria:

* Age \< 18
* no associated vitamin D level

Primary outcomes:
measure: LOS duration in days
timeFrame: 3/9-9/7 2020
measure: Supp O2 flow volume in L/min
timeFrame: 3/9-9/7 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Pueblo
country: United States
facility: Parkview Medical Center
state: Colorado
Study officials:
affiliation: Parkview Medical Center
name: Stephanie Lucas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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):988. doi: 10.3390/nu12040988.
citation: 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:e59177. doi: 10.7554/eLife.59177.
citation: 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