Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04793243
• Other study ID #: CI-07620
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: October 24, 2020

Study information

• Verified date: March 2021
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 24, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Dietary Supplement:
• Vitamin D3
Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3

Locations

Country	Name	City	State
Mexico	Universidad de Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline levels of serum vitamin D in COVID-19 patients	Evaluate serum levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico	At baseline
Primary	Correlation between D-dimer and vitamin D serum levels in COVID-19 patients	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	At baseline
Primary	Correlation between transferrin and vitamin D serum levels in COVID-19 patients	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	At baseline
Primary	Correlation between ferritin and vitamin D serum levels in COVID-19 patients	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	At baseline
Primary	Effects of vitamin D3 supplementation on COVID-19 patients	Serum levels of 25(OH)D (ng/mL) will be determined in the intervention group after 14 days of Vitamin D3 supplementation	After 14 days of supplementation