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Completed

NCT Number: NCT04793243

Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

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

Primary outcomes

  1. Baseline levels of serum vitamin D in COVID-19 patients

    Time frame: At baseline

    Evaluate serum levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico

  2. Correlation between D-dimer and vitamin D serum levels in COVID-19 patients

    Time frame: 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

  3. Correlation between transferrin and vitamin D serum levels in COVID-19 patients

    Time frame: 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

  4. Correlation between ferritin and vitamin D serum levels in COVID-19 patients

    Time frame: 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

  5. Effects of vitamin D3 supplementation on COVID-19 patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2021
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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