Clinical trial NCT04535791: Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Vitamin D
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Infantil de Mexico Federico Gomez
First posted: 2020-09-02
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants with COVID-19
timeFrame: 45 days
measure: Number of Participants with hospitalization for COVID-19
timeFrame: 45 days
Secondary outcomes:
measure: Serum concentration of 25 (OH) vitamin D
timeFrame: the beginning and through study completion, an average of 45 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Centro Medico Nacional Siglo XXI
state: Distrito Federal
Study officials:
affiliation: Coordinación de Investigación en Salud, Mexico
name: Miguel Angel Villasis-Keever
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villasis-Keever MA, Lopez-Alarcon MG, Miranda-Novales G, Zurita-Cruz JN, Barrada-Vazquez AS, Gonzalez-Ibarra J, Martinez-Reyes M, Grajales-Muniz C, Santacruz-Tinoco CE, Martinez-Miguel B, Maldonado-Hernandez J, Cifuentes-Gonzalez Y, Klunder-Klunder M, Garduno-Espinosa J, Lopez-Martinez B, Parra-Ortega I. Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. A Randomized Clinical Trial. Arch Med Res. 2022 Jun;53(4):423-430. doi: 10.1016/j.arcmed.2022.04.003. Epub 2022 Apr 18.