Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico

NCT ID: NCT04793243

Last Updated: 2021-03-11

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

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2020-10-24

Brief Summary

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The immunomodulatory effects of vitamin D are known to be beneficial in viral infections, it is also known that its deficiency is associated with a worse prognosis of COVID-19. This study aimed to determine the baseline vitamin D serum concentrations in asymptomatic or mildly symptomatic COVID-19 outpatients, as well as to evaluate the effects of supplementation with 10,00 IU/daily of vitamin D3 and its relationship with biochemical parameters and clinical features.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

Formed by 22 patients that received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3

Control group

Formed by 20 patients that did not receive supplementation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D3

Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Intervention group: Patients with positive PCR for COVID-19 of both sexes supplemented with vitamin D
* Control group: Patients with positive PCR for COVID-19 of both sexes
* Both groups: Mexican individuals, after signing the informed consent letter and over 18 years of age.

Exclusion Criteria

• Diseases that compromise the absorption of Vitamin D; Crohn's disease, cystic fibrosis, and celiac disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Guadalajara

OTHER

Sponsor Role lead

Responsible Party

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Jose Francisco Munoz Valle

Provost of the University Center of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José F Muñoz-Valle, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

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Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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CI-07620

Identifier Type: -

Identifier Source: org_study_id

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