Back to resultsVitamin D3 Levels in COVID-19 Outpatients From Western Mexico
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19 focused on measuring vitamin D, Latin America, supplementation
Eligibility Criteria
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.
Sites / Locations
- Universidad de Guadalajara
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Formed by 22 patients that received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3
Formed by 20 patients that did not receive supplementation
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04793243
Brief Title
Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico
Official Title
Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico: Clinical Correlation and Effect of Its Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
October 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
vitamin D, Latin America, supplementation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Formed by 22 patients that received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Formed by 20 patients that did not receive supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3
Primary Outcome Measure Information:
Title
Baseline levels of serum vitamin D in COVID-19 patients
Description
Evaluate serum levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico
Time Frame
At baseline
Title
Correlation between D-dimer and vitamin D serum levels in COVID-19 patients
Description
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
Time Frame
At baseline
Title
Correlation between transferrin and vitamin D serum levels in COVID-19 patients
Description
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
Time Frame
At baseline
Title
Correlation between ferritin and vitamin D serum levels in COVID-19 patients
Description
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
Time Frame
At baseline
Title
Effects of vitamin D3 supplementation on COVID-19 patients
Description
Serum levels of 25(OH)D (ng/mL) will be determined in the intervention group after 14 days of Vitamin D3 supplementation
Time Frame
After 14 days of supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José F Muñoz-Valle, Dr.
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico
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