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

NCT04535791 | Completed Phase 3 DMC

• 1 other identifier: R-2020-785-090
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Vitamin D

Outcome Measures

Primary Outcomes (2)

• Number of Participants with COVID-19

  cases confirmed by RT-PCR for SARS-CoV-2, or by antibody detection.

  45 days

• Number of Participants with hospitalization for COVID-19

  participants who, having developed SARS-CoV-2 infection, require hospitalization for the same condition.

  45 days

Secondary Outcomes (1)

• Serum concentration of 25 (OH) vitamin D

  the beginning and through study completion, an average of 45 days

Study Arms (2)

cholecalciferol (Vitamin D)

EXPERIMENTAL

cholecalciferol 4,000 IU orally daily (1 capsule) for 30 days

Drug: Cholecalciferol

Starch

PLACEBO COMPARATOR

Starch 500 mg orally daily (1 capsule) for 30 days

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

4,000 IU orally daily for 30 days

Also known as: vitamin D

Starch; cholecalciferol (Vitamin D)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator

Study Sites (1)

Hospital Centro Medico Nacional Siglo XXI

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (1)

• 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.

  PMID: 35487792 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Miguel Angel Villasis-Keever

  Coordinación de Investigación en Salud, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Blinded randomized clinical trial

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: September 2, 2020
• Study Start: July 15, 2020
• Primary Completion: December 30, 2020
• Study Completion: July 15, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

ME (1)