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

NCT ID: NCT04535791

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-07-15

Brief Summary

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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

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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.

Conditions

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Covid19 Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinded randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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cholecalciferol (Vitamin D)

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

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

4,000 IU orally daily for 30 days

Starch

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

Group Type PLACEBO_COMPARATOR

Cholecalciferol

Intervention Type DRUG

4,000 IU orally daily for 30 days

Interventions

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Cholecalciferol

4,000 IU orally daily for 30 days

Intervention Type DRUG

Other Intervention Names

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vitamin D

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Infantil de Mexico Federico Gomez

OTHER

Sponsor Role collaborator

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Miguel Angel Villasis Keever

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel Angel Villasis-Keever

Role: PRINCIPAL_INVESTIGATOR

Coordinación de Investigación en Salud, Mexico

Locations

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Hospital Centro Medico Nacional Siglo XXI

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 35487792 (View on PubMed)

Other Identifiers

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R-2020-785-090

Identifier Type: -

Identifier Source: org_study_id