Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico

Study Overview
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Dietary Supplement: Vitamin D3


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, Latin America, supplementation