Covid-19NCT05384574
Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients
A study testing cholecalciferol in people with Covid-19 and Respiratory Distress Syndrome, run by University Hospital of Split at 1 site in Croatia.
Trial summary
Single center, open label randomized clinical trial. Study location: tertiary hospital center (University Hospital Split, Croatia). All COVID-19 patients with positive PCR test admitted to ICU and in need for respiratory support will be eligible for inclusion in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Respiratory Distress Syndrome, Vitamin D Deficiency
- What is being tested?
- cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 22 Nov 2021to Jul 2022
- 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
- Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.
Who cannot join
- Patients will be excluded from study in case of calcium levels that are consistently above normal serum range (> 2.6 mmol/L, > 10.5 mg/dL) or if vitamin D levels are > 150 nmol/L.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients - Randomized Controlled Trial
Single center, open label randomized clinical trial.
Study location: tertiary hospital center (University Hospital Split, Croatia). All COVID-19 patients with positive PCR test admitted to ICU and in need for respiratory support will be eligible for inclusion in this study.
Read more
Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.
Intervention:
All patients included in this study will receive standard of care. Patients randomized into intervention group will be receiving 10 000 IU of cholecalciferol daily. Supplement will be administered orally or via gastric tube during ICU stay or for at least 14 days in case of ICU discharge before day 14. Supplementation will begin within 48 hours of admission to ICU. Supplement will be prepared and administered by experienced nursing staff. For patients receiving supplementation, vitamin D levels will be checked on days 7 and 14. In case that vitamin D levels are > 150 nmol/l or if the calcium levels are consistently > 2.6 mmol/l, further supplementation will be stopped.
Outcomes:
Primary outcome is number of days spent on ventilator.
Secondary outcomes: all-cause mortality on day 28, all-cause mortality on day 60, mortality at hospital discharge, clinical improvement at day 28 (WHO clinical progression scale), days spent in ICU, days spent in hospital after discharge from ICU, need for dialysis at day 28, bacterial superinfections, neutrophile to lymphocyte ratio, disease severity (CRP levels, PaO2/FiO2 ratio, D-dimer levels, fibrinogen, ferritin, PCT), adverse outcomes.
Hypothesis: patients receiving Vitamin D supplementation will have shorter number of days spent on mechanical ventilation.
- Being tested
- cholecalciferol
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
daily supplementation of cholecalciferol, 10 000 IU, during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients with low levels of Vitamin D on admission to ICU randomized to receive vitamin D supplementation Receives: Dietary Supplement: cholecalciferol |
| Control | No intervention | Patients with low levels of Vitamin D on admission to ICU not receiving vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days on mechanical ventilation
Number of days spent on mechanical ventilation for each patient
Measured: Daily, through study completion, on average 6 months
Secondary outcomes (12)
All-cause mortality on day 28
Number of patients alive on day 28
Measured: day 28
All-cause mortality on day 60
Number of patients alive on day 60
Measured: day 60
clinical improvement at day 28
World Health Organization Clinical progression scale. Values are from 0 to 10 with higher score meaning worse clinical status
Measured: day 28
Number of days spent in ICU
Number of days spent in Intensive care unit for each patient
Measured: Daily, through study completion, on average 6 months
Number of days spent in hospital after ICU discharge
Number of days spent in hospital for each patient
Measured: Daily, through study completion, on average 6 months
Acute renal failure
Number of patients with need for renal replacement therapy
Measured: Day 28
bacterial superinfections
Number of patients with bacterial superinfections during hospitalization
Measured: Daily, through study completion, on average 6 months
CRP levels (mg/ml)
blood tests will be taken daily during hospital stay
Measured: Daily, through study completion, on average 6 months
prokalcitonin levels (ng/ml)
blood tests will be taken daily during hospital stay
Measured: Daily, through study completion, on average 6 months
fibrinogen levels (g/L)
blood tests will be taken daily during hospital stay
Measured: Daily, through study completion, on average 6 months
D-dimer levels (mg/l)
blood tests will be taken daily during hospital stay
Measured: Daily, through study completion, on average 6 months
adverse outcomes
Number of patients with elevated serum calcium levels
Measured: Daily, through study completion, on average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start22 Nov 2021
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lenko Saric, University Hospital of Split
- Investigators
- Lenko Saric, M.D. PhD, Principal investigator, University Hospital Split, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384574
- Sponsor's protocol ID
- 2181-147/01/06/M.S.-21-02
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05384574
- Acronym / sponsor ID
- 2181-147/01/06/M.S.-21-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 20 May 2022 (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.
Single center, open label randomized clinical trial.
Study location: tertiary hospital center (University Hospital Split, Croatia). All COVID-19 patients with positive PCR test admitted to ICU and in need for respiratory support will be eligible for inclusion in this study.
Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.
Intervention:
All patients included in this study will receive standard of care. Patients randomized into intervention group will be receiving 10 000 IU of cholecalciferol daily. Supplement will be administered orally or via gastric tube during ICU stay or for at least 14 days in case of ICU discharge before day 14. Supplementation will begin within 48 hours of admission to ICU. Supplement will be prepared and administered by experienced nursing staff. For patients receiving supplementation, vitamin D levels will be checked on days 7 and 14. In case that vitamin D levels are > 150 nmol/l or if the calcium levels are consistently > 2.6 mmol/l, further supplementation will be stopped.
Outcomes:
Primary outcome is number of days spent on ventilator.
Secondary outcomes: all-cause mortality on day 28, all-cause mortality on day 60, mortality at hospital discharge, clinical improvement at day 28 (WHO clinical progression scale), days spent in ICU, days spent in hospital after discharge from ICU, need for dialysis at day 28, bacterial superinfections, neutrophile to lymphocyte ratio, disease severity (CRP levels, PaO2/FiO2 ratio, D-dimer levels, fibrinogen, ferritin, PCT), adverse outcomes.
Hypothesis: patients receiving Vitamin D supplementation will have shorter number of days spent on mechanical ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: cholecalciferolPatients with low levels of Vitamin D on admission to ICU randomized to receive vitamin D supplementation |
| Control | No intervention | –Patients with low levels of Vitamin D on admission to ICU not receiving vitamin D supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.
Key exclusion criteria (1 listed)
- Patients will be excluded from study in case of calcium levels that are consistently above normal serum range (> 2.6 mmol/L, > 10.5 mg/dL) or if vitamin D levels are > 150 nmol/L.
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 |
|---|---|---|
| cholecalciferoldaily supplementation of cholecalciferol, 10 000 IU, during 14 days | Dietary supplement | Intervention |
Primary outcome
number of days on mechanical ventilation
Time frame: Daily, through study completion, on average 6 months
Number of days spent on mechanical ventilation for each patient
12 secondary outcomes
All-cause mortality on day 28
Time frame: day 28
All-cause mortality on day 60
Time frame: day 60
clinical improvement at day 28
Time frame: day 28
Number of days spent in ICU
Time frame: Daily, through study completion, on average 6 months
Number of days spent in hospital after ICU discharge
Time frame: Daily, through study completion, on average 6 months
Acute renal failure
Time frame: Day 28
bacterial superinfections
Time frame: Daily, through study completion, on average 6 months
CRP levels (mg/ml)
Time frame: Daily, through study completion, on average 6 months
prokalcitonin levels (ng/ml)
Time frame: Daily, through study completion, on average 6 months
fibrinogen levels (g/L)
Time frame: Daily, through study completion, on average 6 months
D-dimer levels (mg/l)
Time frame: Daily, through study completion, on average 6 months
adverse outcomes
Time frame: Daily, through study completion, on average 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- 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.
Lenko Saric, M.D. PhD principal investigator
University Hospital Split, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol in people with Covid-19 and Respiratory Distress Syndrome, run by University Hospital of Split at 1 site in Croatia.
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 1 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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 Croatia. 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?
Results are not available in the source record.
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?
number of days on mechanical ventilation (time frame: Daily, through study completion, on average 6 months). 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 20 May 2022.