Evaluation of the likely beneficial effects of vitamin D on infection with coronavirus.

Usefulness of vitamin D on morbidity and mortality of SARS-COV-2 virus infection (Covid-19) at the Central University Hospital of Asturias - Vitamin D and COVID-19

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002274-28-ES

Enrollment

Registered

2020-05-21

Start date

2020-05-19

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-COV-2 infection MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Videsil 100.000 UI Pharmaceutical Form: Oral solution in sachet INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Other descriptive name: VITAMIN D3 Concentration unit: IU internatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients treated in the ER or admitted to the HUCA Hospitalization unit. • Diagnosis of COVID19 demonstrated by positive PCR for SARS COV2 prior to randomization. • Age> = 18 years. • That they have accepted to participate in the study through informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • When discharge or a fatal outcome is expected within the next 48 hours. • Obvious cognitive impairment (inability to communicate). • PCR for SARS-COV 2 negative despite radiological, analytical and clinical findings compatible with this type of infection. • Allergy to vitamin D. • Patients who are receiving, or have received in the past 3 months, any form of vitamin D • Pregnant women

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to analyze if the administration of a single dose of native vitamin D (100,000 IU of Colecalciferol) (1 ampoule of 100,000) has an influence on the evolution of clinical and biochemical parameters of the disease.;Secondary Objective: Not applicable;Primary end point(s): • Percentage and time of patients who have a negative SARS-CoV-2 viral load • Clinical symptoms and time during hospitalization • Improvement of biochemical and molecular parameters of inflammation • Overall mean hospital stay • Percentage of patients requiring transfer to the ICU • Average stay in ICU • Mortality during follow-up;Timepoint(s) of evaluation of this end point: 14 and 21 days or until a negative SARS-CoV-2 test every 7 days.	—

Measure

Time frame

Main Objective: The objective of the study is to analyze if the administration of a single dose of native vitamin D (100,000 IU of Colecalciferol) (1 ampoule of 100,000) has an influence on the evolution of clinical and biochemical parameters of the disease.;Secondary Objective: Not applicable;Primary end point(s): • Percentage and time of patients who have a negative SARS-CoV-2 viral load • Clinical symptoms and time during hospitalization • Improvement of biochemical and molecular parameters of inflammation • Overall mean hospital stay • Percentage of patients requiring transfer to the ICU • Average stay in ICU • Mortality during follow-up;Timepoint(s) of evaluation of this end point: 14 and 21 days or until a negative SARS-CoV-2 test every 7 days.

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Spain

Contacts

Public ContactManaging director

Fundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA)

enrique.caso@gmail.com3498510 99 05

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 13, 2026