Baseline Vitamin D Deficiency and COVID-19 Disease Severity

Completed

• Conditions: Vitamin D Deficiency; Covid19
• Interventions: Other: Vitamin D

• Registration Number: NCT04628000
• Lead Sponsor: Parkview Medical Center

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).

Study Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-13
• Primary Completion: 2021-10-14
• Study Completion: 2022-04-14
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Covid 19 +
• Vitamin D level

Exclusion Criteria

• Age < 18
• no associated vitamin D level

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitamin D deficiency and COVID19	Vitamin D	Vitamin D deficiency and COVID19

Primary Outcome Measures

Name	Time	Method
LOS duration in days	3/9-9/7 2020	Length of stay
Supp O2 flow volume in L/min	3/9-9/7 2020	Supplemental Oxygen need

Trial Locations

Locations (1)

Parkview Medical Center; 🇺🇸 Pueblo, Colorado, United States