Covid19NCT04793243
Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico
A study testing Vitamin D3 in people with Covid19, run by University of Guadalajara at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 17 Aug 2020to 24 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diseases that compromise the absorption of Vitamin D; Crohn's disease, cystic fibrosis, and celiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Covid19
- Being tested
- Vitamin D3
- Keywords
- vitamin D, Latin America, supplementation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Formed by 22 patients that received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3 Receives: Dietary Supplement: Vitamin D3 |
| Control group | No intervention | Formed by 20 patients that did not receive supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After 14 days of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start17 Aug 2020
- Primary completion10 Oct 2020
- Study completion24 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Francisco Munoz Valle, University of Guadalajara
- Investigators
- José F Muñoz-Valle, Dr., Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793243
- Sponsor's protocol ID
- CI-07620
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico: Clinical Correlation and Effect of Its Supplementation
- ClinicalTrials.gov ID
- NCT04793243
- Acronym / sponsor ID
- CI-07620
- Conditions
- Covid19
- Keywords
- vitamin D, Latin America, supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 24 Oct 2020 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Vitamin D3Formed by 22 patients that received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3 |
| Control group | No intervention | –Formed by 20 patients that did not receive supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Diseases that compromise the absorption of Vitamin D; Crohn's disease, cystic fibrosis, and celiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3 | Dietary supplement | Intervention group |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José F Muñoz-Valle, Dr. principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Covid19, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline levels of serum vitamin D in COVID-19 patients (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.