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

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ClinicalTrials.gov Identifier: NCT04535791
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Hospital Infantil de Mexico Federico Gomez
Information provided by (Responsible Party):
Miguel Angel Villasis Keever, Coordinación de Investigación en Salud, Mexico

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Covid19 Vitamin D Drug: Cholecalciferol Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded randomized clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: To ensure that participants are unaware of the intervention they are receiving, both the capsules containing vitamin D3 and the placebo will be the same. Cholecalciferol (Vitamin D3), 4000UI tablets will be purchased from the MEDIX laboratory (trade name HISTOFIL). The placebo will consist of corn starch, which will be purchased from a supplier, who packages it in a 25 kg bag. As it is a dry product, the supplier guarantees that the corn starch maintains its characteristics for 3 years, as long as it is stored in closed container, in a cool and dry place, free of moisture, dust, insects and rodents. The encapsulation of the placebo and vitamin D3 will be carried out by an external supplier with capsules of the capsugel brand, maintaining quality control to avoid contamination of the product during storage and encapsulation. An external researcher will have a list to which group each subject belongs, without being in contact with the research.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: cholecalciferol (Vitamin D)
cholecalciferol 4,000 IU orally daily for 30 days
Drug: Cholecalciferol
4,000 IU orally daily for 30 days
Other Name: vitamin D

Placebo Comparator: Starch
Starch 500 mg orally daily for 30 days
Drug: Cholecalciferol
4,000 IU orally daily for 30 days
Other Name: vitamin D




Primary Outcome Measures :
  1. Number of Participants with COVID-19 [ Time Frame: 45 days ]
    cases confirmed by RT-PCR for SARS-CoV-2, or by antibody detection.

  2. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535791


Contacts
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Contact: Carla Castuera Martinez 525556276900 ext 21218 carla_martinez@imss.gob.mx
Contact: Miguel Angel Villasis-Keever 56276900 miguel.villasis@gmail.com

Locations
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Mexico
Hospital Centro Medico Nacional Siglo XXI Recruiting
Mexico City, Distrito Federal, Mexico, 06720
Contact: Miguel Angel Villasis-Keever, MD    +5256276900 ext 22701    miguel.villasis@gmail.com   
Contact: Jessie Zurita-Cruz, MD    +525554194513 ext Keever    zuritajn@hotmail.com   
Principal Investigator: Miguel Angel Villasis-Keever, PhD         
Sub-Investigator: Mardia Lopez-Alarcon, PhD         
Sub-Investigator: Guadalupe Miranda-Novales, PhD         
Sub-Investigator: Jessie Zurita-Cruz, PhD         
Sub-Investigator: Concepcion Grajales-Muñiz, PhD         
Sub-Investigator: Clara Santacruz-Tinoco, PhD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Hospital Infantil de Mexico Federico Gomez
Investigators
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Principal Investigator: Miguel Angel Villasis-Keever Coordinación de Investigación en Salud, Mexico
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Responsible Party: Miguel Angel Villasis Keever, Clinical Professor, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT04535791    
Other Study ID Numbers: R-2020-785-090
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents