Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers
Condition: Covid19; Vitamin D
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): 4,000 IU orally daily for 30 days
Other intervention name(s): vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded randomized clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment