Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers (COVID-19)

December 7, 2021 updated by: Miguel Angel Villasis Keever, Coordinación de Investigación en Salud, Mexico

Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring or Evolving Into the Severe Form of COVID-19 in Healthcare Workers Caring for Patients With the Disease. Blinded Randomized Clinical Trial

In a blinded randomized clinical trial, which will include health workers (doctors, residents, nurses, stretcher-bearers, technicians, hygiene and cleaning) who are members of the health teams that care for patients with COVID-19. Two groups will be formed: the Vitamin D group taking 4,000 IU orally daily for 30 days, the control group being given a placebo during the same time period.

Participants will be adults, who have not had COVID-19 disease, and who sign the informed consent. At the beginning of the study anthropometric variables (weight, height, BMI) will be taken, the short medical history can be identified to identify comorbidities, and a fasting blood sample will be taken to determine changes in Vitamin D (25 (OH) Vitamin D), in addition to RT-PCR saliva samples, as well as detection of serum antibodies to determine whether or not they have SARS-CoV-2 disease. Participants will follow each other 45 days. Those with COVID-19 disease will be monitored frequently to determine the course of the disease. At the end of 45 days, new samples will be taken to determine levels of vitamin D and antibodies against SARS-Cov-2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a blinded randomized clinical trial, which will include health workers (doctors, residents, nurses, stretcher-bearers, technicians, hygiene and cleaning) who are members of the health teams that care for patients with COVID-19. Participants with a history of having COVID-19 disease or who are consuming vitamin D at that time will be excluded. Through randomization, two groups will be formed: the Vitamin D group taking 4,000 IU orally daily for 30 days, the control group being given a placebo (starch) during the same time period. Participants and researchers will be blinded regarding the maneuver.

At the beginning of the study anthropometric variables (weight, height, BMI) will be taken, the short medical history can be identified to identify comorbidities such as diabetes mellitus, hypertension or obesity, and a fasting blood sample will be taken to determine the changes in Vitamin D (25 (OH) VD), in addition to saliva samples by RT-PCR, as well as detection of antibodies in serum to determine whether or not they have SARS-CoV-2 disease. Participants who test positive for COVID-19 will be eliminated by the RT-PCR test. Participants will follow each other 45 days. Contacted weekly to verify the consumption of the capsules, as well as evaluation of adverse effects of vitamin D. Monitored for suspicious data of COVID-19 and in case of presenting the disease by COVID-19, a study will be carried out to confirm the infection through RT-PCR and will be monitored to determine the course of the disease. At the end of 45 days, new samples will be taken to determine levels of vitamin D and antibodies against SARS-Cov-2.

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 3

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

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 06720
        • Hospital Centro Medico Nacional Siglo XXI

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health workers in areas of care for patients with COVI-19
  • Adults
  • Men and women.
  • That they agree to participate in the study by signing the letter of informed consent

Exclusion Criteria:

  • Those who know that they have already suffered from COVID-19
  • Those who have received a vitamin D supplement in the previous two weeks.
  • Difficulty obtaining blood samples

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cholecalciferol (Vitamin D)
cholecalciferol 4,000 IU orally daily (1 capsule) for 30 days
Drug: Cholecalciferol
4,000 IU orally daily for 30 days
Other Names:
  • vitamin D
Placebo Comparator: Starch
Starch 500 mg orally daily (1 capsule) for 30 days
Drug: Cholecalciferol
4,000 IU orally daily for 30 days
Other Names:
  • vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with COVID-19
Time Frame: 45 days
cases confirmed by RT-PCR for SARS-CoV-2, or by antibody detection.
45 days
Number of Participants with hospitalization for COVID-19
Time Frame: 45 days
participants who, having developed SARS-CoV-2 infection, require hospitalization for the same condition.
45 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentration of 25 (OH) vitamin D
Time Frame: the beginning and through study completion, an average of 45 days
Serum concentration of 25 (OH) vitamin D at the beginning and through study completion, an average of 45 days
the beginning and through study completion, an average of 45 days

Collaborators and Investigators

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

Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

Hospital Infantil de Mexico Federico Gomez

Investigators

  • Principal Investigator: Miguel Angel Villasis-Keever, Coordinación de Investigación en Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 15, 2020

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2020-785-090

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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