Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico

March 9, 2021 updated by: Jose Francisco Munoz Valle, University of Guadalajara

Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico: Clinical Correlation and Effect of Its Supplementation

The immunomodulatory effects of vitamin D are known to be beneficial in viral infections, it is also known that its deficiency is associated with a worse prognosis of COVID-19. This study aimed to determine the baseline vitamin D serum concentrations in asymptomatic or mildly symptomatic COVID-19 outpatients, as well as to evaluate the effects of supplementation with 10,00 IU/daily of vitamin D3 and its relationship with biochemical parameters and clinical features.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Universidad de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Intervention group: Patients with positive PCR for COVID-19 of both sexes supplemented with vitamin D
  • Control group: Patients with positive PCR for COVID-19 of both sexes
  • Both groups: Mexican individuals, after signing the informed consent letter and over 18 years of age.

Exclusion criteria:

• Diseases that compromise the absorption of Vitamin D; Crohn's disease, cystic fibrosis, and celiac disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Formed by 22 patients that received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3
Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3
No Intervention: Control group
Formed by 20 patients that did not receive supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline levels of serum vitamin D in COVID-19 patients
Time Frame: At baseline
Evaluate serum levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
At baseline
Correlation between D-dimer and vitamin D serum levels in COVID-19 patients
Time Frame: At baseline
Serum levels of D-dimer (ng/mL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
At baseline
Correlation between transferrin and vitamin D serum levels in COVID-19 patients
Time Frame: At baseline
Serum levels of transferrin (mg/dL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
At baseline
Correlation between ferritin and vitamin D serum levels in COVID-19 patients
Time Frame: At baseline
Serum levels of ferritin (ng/mL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
At baseline
Effects of vitamin D3 supplementation on COVID-19 patients
Time Frame: After 14 days of supplementation
Serum levels of 25(OH)D (ng/mL) will be determined in the intervention group after 14 days of Vitamin D3 supplementation
After 14 days of supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: José F Muñoz-Valle, Dr., University of Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Actual)

October 10, 2020

Study Completion (Actual)

October 24, 2020

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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