We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535791
Recruitment Status : Completed
First Posted : September 2, 2020
Last Update Posted : December 22, 2021
Sponsor:
Collaborator:
Hospital Infantil de Mexico Federico Gomez
Information provided by (Responsible Party):
Miguel Angel Villasis Keever, Coordinación de Investigación en Salud, Mexico

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE September 2, 2020
Last Update Posted Date December 22, 2021
Actual Study Start Date  ICMJE July 15, 2020
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
  • Number of Participants with COVID-19 [ Time Frame: 45 days ]
    cases confirmed by RT-PCR for SARS-CoV-2, or by antibody detection.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2020)		 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring COVID-19 in Healthcare Workers
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Covid19
  • Vitamin D
Intervention  ICMJE Drug: Cholecalciferol
4,000 IU orally daily for 30 days
Other Name: vitamin D
Study Arms  ICMJE
  • Experimental: cholecalciferol (Vitamin D)
    cholecalciferol 4,000 IU orally daily (1 capsule) for 30 days
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Starch
    Starch 500 mg orally daily (1 capsule) for 30 days
    Intervention: Drug: Cholecalciferol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2021)		 321
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)		 400
Actual Study Completion Date  ICMJE July 15, 2021
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04535791
Other Study ID Numbers  ICMJE R-2020-785-090
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Miguel Angel Villasis Keever, Coordinación de Investigación en Salud, Mexico
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Coordinación de Investigación en Salud, Mexico
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hospital Infantil de Mexico Federico Gomez
Investigators  ICMJE
Principal Investigator: Miguel Angel Villasis-Keever Coordinación de Investigación en Salud, Mexico
PRS Account Coordinación de Investigación en Salud, Mexico
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP