NCT04334005

Brief Summary

The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

March 29, 2020

Last Update Submit

April 3, 2020

Conditions

Patients Infected With COVID-19

Outcome Measures

Primary Outcomes (1)

  • Composite of cumulative death (i.e. mortality) for all causes and for specific causes.

    Through study completion, an average of 10 weeks

Secondary Outcomes (10)

  • Necessity of invasive assisted ventilation

    Through study completion, an average of 10 weeks

  • Necessity of non-invasive assisted ventilation

    Through study completion, an average of 10 weeks

  • Intensive care unit admission

    Through study completion, an average of 10 weeks

  • Post-anesthesia care unit admission

    Through study completion, an average of 10 weeks

  • Hospital admission

    Through study completion, an average of 10 weeks

  • +5 more secondary outcomes

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.

Dietary Supplement: Vitamin D

Intervention group

EXPERIMENTAL

25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

The intervention group will receive a single dose of 25000 UI of vitamin D supplement in addition to prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations. Vitamin D supplementation will be taken in the morning together with a toast with olive oil to facilitate its absorption.

Intervention groupUsual care

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections.

You may not qualify if:

  • Patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced COVID-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad de Granada

Granada, Andalusia, 18071, Spain

Location

Medicine Faculty

Granada, 18001, Spain

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Manuel J Castillo, MD, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel J Castillo, MD, PhD

CONTACT

+34 649440850mcgarzon@ugr.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 29, 2020

First Posted

April 3, 2020

Study Start

April 10, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

ES(2)