Effect of Vitamin D on Morbidity and Mortality of the COVID-19

NCT ID: NCT04552951

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-04

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19).

Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Efficacy parameters to compare both groups (vitamin D and No vitamin D).

Time to reach undetectable levels of SARS COV2 Infection.

Time of normalization of symptoms and clinical parameters.

Time of normalization of radiological images.

Time of normalization of biochemical markers.

Time of normalization of molecular inflammatory markers.

Transfer to the Intensive care Unit.

Mortality rate.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active

Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

Single doe of 100.000 IU

Control

No vitamin D

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cholecalciferol

Single doe of 100.000 IU

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vitamin D

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \> 18 year
* Diagnosis of COVID-19
* Accept to participate in the study ( consent)

Exclusion Criteria

* Pregnancy
* Allergy to vitamin D
* Consumption of any form of vitamin D during the last 3 months
* Expected fatal outcome in the next 24 hours
* Cognitive deterioration
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitario Central de Asturias

OTHER

Sponsor Role collaborator

Instituto de Investigación Sanitaria del Principado de Asturias

UNKNOWN

Sponsor Role collaborator

Fundación para la Investigación Biosanitaria del Principado de Asturias

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jorge B Cannata-Andía, MD PhD

Role: CONTACT

*34 985 106137

Juan Pérez-Ortega

Role: CONTACT

*34 985109905

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jorge B Cannata-Andía, MD PhD

Role: primary

*34 985106137

Juan Pérez-Ortega

Role: backup

*34 985 109905

References

Explore related publications, articles, or registry entries linked to this study.

Cannata-Andia JB, Diaz-Sottolano A, Fernandez P, Palomo-Antequera C, Herrero-Puente P, Mouzo R, Carrillo-Lopez N, Panizo S, Ibanez GH, Cusumano CA, Ballarino C, Sanchez-Polo V, Pefaur-Penna J, Maderuelo-Riesco I, Calvino-Varela J, Gomez MD, Gomez-Alonso C, Cunningham J, Naves-Diaz M, Douthat W, Fernandez-Martin JL; COVID-VIT-D trial collaborators. A single-oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve outcomes in the COVID-19 disease: the COVID-VIT-D-a randomised multicentre international clinical trial. BMC Med. 2022 Feb 18;20(1):83. doi: 10.1186/s12916-022-02290-8.

Reference Type DERIVED
PMID: 35177066 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-019-PF-CAANJ

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vitamin D and COVID-19 Management
NCT04385940 COMPLETED PHASE3
Oral 25-hydroxyvitamin D3 and COVID-19
NCT04386850 UNKNOWN PHASE2/PHASE3