Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico

Sponsor

University of Guadalajara (Other)

Overall Status

Completed

CT.gov ID

NCT04793243

Collaborator

(none)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Dietary Supplement: Vitamin D3	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico: Clinical Correlation and Effect of Its Supplementation

Actual Study Start Date :

Aug 17, 2020

Actual Primary Completion Date :

Oct 10, 2020

Actual Study Completion Date :

Oct 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Formed by 22 patients that received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3	Dietary Supplement: Vitamin D3 Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3
No Intervention: Control group Formed by 20 patients that did not receive supplementation

Arm

Intervention/Treatment

Experimental: Intervention group

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

Dietary Supplement: Vitamin D3

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

No Intervention: Control group

Formed by 20 patients that did not receive supplementation

Outcome Measures

Primary Outcome Measures

Baseline levels of serum vitamin D in COVID-19 patients [At baseline]
Evaluate serum levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
Correlation between D-dimer and vitamin D serum levels in COVID-19 patients [At baseline]
Serum levels of D-dimer (ng/mL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
Correlation between transferrin and vitamin D serum levels in COVID-19 patients [At baseline]
Serum levels of transferrin (mg/dL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
Correlation between ferritin and vitamin D serum levels in COVID-19 patients [At baseline]
Serum levels of ferritin (ng/mL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
Effects of vitamin D3 supplementation on COVID-19 patients [After 14 days of supplementation]
Serum levels of 25(OH)D (ng/mL) will be determined in the intervention group after 14 days of Vitamin D3 supplementation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.