Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04535791 |
| Other study ID # |
R-2020-785-090 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2020 |
| Est. completion date |
July 15, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Coordinación de Investigación en Salud, Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
