NCT04628000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2022

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

November 11, 2020

Last Update Submit

September 30, 2022

Conditions

Vitamin D DeficiencyCovid19

Keywords

prognosis

Outcome Measures

Primary Outcomes (2)

  • LOS duration in days

    Length of stay

    3/9-9/7 2020

  • Supp O2 flow volume in L/min

    Supplemental Oxygen need

    3/9-9/7 2020

Study Arms (1)

Vitamin D deficiency and COVID19

Vitamin D deficiency and COVID19

Other: Vitamin D

Interventions

Vitamin DOTHER

Clinical Correlation

Also known as: Vitamin D deficiency
Vitamin D deficiency and COVID19

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Covid 19 +
  • Vitamin D level

You may not qualify if:

  • Age \< 18
  • no associated vitamin D level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkview Medical Center

Pueblo, Colorado, 81003, United States

Location

Related Publications (4)

  • 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.

    PMID: 30675873BACKGROUND

  • 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.

    PMID: 32252338BACKGROUND

  • 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.

    PMID: 32633718BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Vitamin D DeficiencyCOVID-19

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Stephanie Lucas, MD

    Parkview Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Committee Chair

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 13, 2020

Study Start

October 27, 2020

Primary Completion

October 14, 2021

Study Completion

April 14, 2022

Last Updated

October 4, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)