- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793243
Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico
March 9, 2021 updated by: Jose Francisco Munoz Valle, University of Guadalajara
Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico: Clinical Correlation and Effect of Its Supplementation
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44340
- Universidad de Guadalajara
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At baseline
|
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
|
At baseline
|
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
|
At baseline
|
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
|
At baseline
|
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
|
After 14 days of supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: José F Muñoz-Valle, Dr., University of Guadalajara
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2020
Primary Completion (Actual)
October 10, 2020
Study Completion (Actual)
October 24, 2020
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
March 9, 2021
First Posted (Actual)
March 11, 2021
Study Record Updates
Last Update Posted (Actual)
March 11, 2021
Last Update Submitted That Met QC Criteria
March 9, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- CI-07620
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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