Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535791
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2020-07-30
Brief Title:
Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers
Sponsor:
Coordinación de Investigación en Salud Mexico
Organization:
Coordinación de Investigación en Salud Mexico
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-19
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 4000 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
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 4000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None