Baseline Vitamin D Deficiency and COVID-19 Disease Severity

Sponsor
Parkview Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04628000
Collaborator
(none)
50
1
17.5
2.8

Study Details

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 Phase
  • 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

Study Type:
Observational
Anticipated 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 :
Oct 27, 2020
Anticipated Primary Completion Date :
Oct 14, 2021
Anticipated Study Completion Date :
Apr 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Vitamin D deficiency and COVID19

Vitamin D deficiency and COVID19

Other: Vitamin D
Clinical Correlation
Other Names:
  • Vitamin D deficiency
  • Outcome Measures

    Primary Outcome Measures

    1. LOS duration in days [3/9-9/7 2020]

      Length of stay

    2. Supp O2 flow volume in L/min [3/9-9/7 2020]

      Supplemental Oxygen need

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Covid 19 +

    • Vitamin D level

    Exclusion Criteria:
    • Age < 18

    • no associated vitamin D level

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parkview Medical Center Pueblo Colorado United States 81003

    Sponsors and Collaborators

    • Parkview Medical Center

    Investigators

    • Principal Investigator: Stephanie Lucas, MD, Parkview Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Doug Duffee, Research Committee Chair, Parkview Medical Center
    ClinicalTrials.gov Identifier:
    NCT04628000
    Other Study ID Numbers:
    • PIRB78
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Nov 16, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Doug Duffee, Research Committee Chair, Parkview Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2020