COVID-19Phase 4COVID-VIT-DNCT04552951
Effect of Vitamin D on Morbidity and Mortality of the COVID-19
A Phase 4 study testing Cholecalciferol in people with COVID-19, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2020to 30 Dec 2020
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 18 year
- Diagnosis of COVID-19
- Accept to participate in the study ( consent)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Jorge B Cannata-Andía, MD PhD, *34 985106137, cannata@hca.es
Juan Pérez-Ortega, *34 985 109905, juan.perez@finba.es
About this study
Official title: Estudio Destinado a Valorar la Utilidad de Vitamina D Sobre Morbilidad y Mortalidad de la infección Por Virus SARS-COV-2 (COVID-19) en el Hospital Universitario Central de Asturias
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.
Read the detailed description
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
- COVID-19
- Being tested
- Cholecalciferol
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D
Single doe of 100.000 IU
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed Receives: Drug: Cholecalciferol |
| Control | No intervention | No vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Percentage of patients dying during hospitalization
Measured: Time to death or hospital discharge in days (average 12 days)
Admission to Intensive Care Unit (ICU)
Percentage of patients admitted to ICU and time in ICU
Measured: Time from hospital admission to discharge in days (average 12 days)
Time of hospitalization
Number of days from hospital admission to discharge
Measured: Time of hospitalization in days (average 12 days)
Clinical changes
Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...)
Measured: At the time of hospital admission and discharge (average 12 days)
Radiological changes
Changes in the percentage of patients with radiological findings of pneumonia and severity
Measured: At the time of hospital admission and discharge (average 12 days)
Calcidiol changes
Calcidiol levels in ng/mL.
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Inflammation markers changes (CRP)
C-reactive protein (CRP) in mg/L
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Inflammation markers changes (IL-6)
Interleukin-6 (IL-6) in pg/mL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Inflammation markers changes (Leucocytes)
Leucocytes in cells per liter
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Inflammation markers changes (D-dimer)
D-dimer in µg/mL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Creatinine)
Creatinine in mg/dL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Ferritin)
Ferritin in µg/L
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Bilirubin)
Bilirubin in mg/dL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Albumin)
Albumin in g/dL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Haemoglobin)
Haemoglobin in g/dL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (HDL cholesterol)
High density lipoprotein (HDL cholesterol) in mg/dL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Procalcitonin)
Procalcitonin in ng/mL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Protonin)
Protonin in ng/L
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Calcium)
Calcium in mg/dL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (Phosphate)
Phosphate in mg/dL
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
General biochemical parameters changes (pO2)
pO2 in mmHg
Measured: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start4 Apr 2020
- Primary completion14 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552951
- Sponsor's protocol ID
- 2020-019-PF-CAANJ
- Acronym
- COVID-VIT-D
- Status last verified
- Sep 2020
- First submitted
- 21 May 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35177066
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Destinado a Valorar la Utilidad de Vitamina D Sobre Morbilidad y Mortalidad de la infección Por Virus SARS-COV-2 (COVID-19) en el Hospital Universitario Central de Asturias
- ClinicalTrials.gov ID
- NCT04552951
- Acronym / sponsor ID
- COVID-VIT-D / 2020-019-PF-CAANJ
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de AsturiasUniversity, hospital or other
- Collaborators
- Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 14 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 17 Sep 2020 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: CholecalciferolReceiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed |
| Control | No intervention | –No vitamin D |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 year
- Diagnosis of COVID-19
- Accept to participate in the study ( consent)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin DSingle doe of 100.000 IU | Drug | Active |
Primary outcome
Mortality
Time frame: Time to death or hospital discharge in days (average 12 days)
Percentage of patients dying during hospitalization
Admission to Intensive Care Unit (ICU)
Time frame: Time from hospital admission to discharge in days (average 12 days)
Percentage of patients admitted to ICU and time in ICU
Time of hospitalization
Time frame: Time of hospitalization in days (average 12 days)
Number of days from hospital admission to discharge
Clinical changes
Time frame: At the time of hospital admission and discharge (average 12 days)
Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...)
Radiological changes
Time frame: At the time of hospital admission and discharge (average 12 days)
Changes in the percentage of patients with radiological findings of pneumonia and severity
Calcidiol changes
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Calcidiol levels in ng/mL.
Inflammation markers changes (CRP)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
C-reactive protein (CRP) in mg/L
Inflammation markers changes (IL-6)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Interleukin-6 (IL-6) in pg/mL
Inflammation markers changes (Leucocytes)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Leucocytes in cells per liter
Inflammation markers changes (D-dimer)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
D-dimer in µg/mL
General biochemical parameters changes (Creatinine)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Creatinine in mg/dL
General biochemical parameters changes (Ferritin)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Ferritin in µg/L
General biochemical parameters changes (Bilirubin)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Bilirubin in mg/dL
General biochemical parameters changes (Albumin)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Albumin in g/dL
General biochemical parameters changes (Haemoglobin)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Haemoglobin in g/dL
General biochemical parameters changes (HDL cholesterol)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
High density lipoprotein (HDL cholesterol) in mg/dL
General biochemical parameters changes (Procalcitonin)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Procalcitonin in ng/mL
General biochemical parameters changes (Protonin)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Protonin in ng/L
General biochemical parameters changes (Calcium)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Calcium in mg/dL
General biochemical parameters changes (Phosphate)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Phosphate in mg/dL
General biochemical parameters changes (pO2)
Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
pO2 in mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Derived from this study: PubMed 35177066Cannata-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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with COVID-19, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge B Cannata-Andía, MD PhD (*34 985 106137, cannata@hca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Time to death or hospital discharge in days (average 12 days)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04552951, which also lists 1 linked publication.
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 17 Sep 2020.