Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients

Covid-19 Clinical Trial

Official title:

Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients - Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05384574
• Other study ID #: 2181-147/01/06/M.S.-21-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: July 2022

Study information

• Verified date: May 2022
• Source: University Hospital of Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• cholecalciferol
daily supplementation of cholecalciferol, 10 000 IU, during 14 days

Locations

Country	Name	City	State
Croatia	University Hospital Split	Split

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days on mechanical ventilation	Number of days spent on mechanical ventilation for each patient	Daily, through study completion, on average 6 months
Secondary	All-cause mortality on day 28	Number of patients alive on day 28	day 28
Secondary	All-cause mortality on day 60	Number of patients alive on day 60	day 60
Secondary	clinical improvement at day 28	World Health Organization Clinical progression scale. Values are from 0 to 10 with higher score meaning worse clinical status	day 28
Secondary	Number of days spent in ICU	Number of days spent in Intensive care unit for each patient	Daily, through study completion, on average 6 months
Secondary	Number of days spent in hospital after ICU discharge	Number of days spent in hospital for each patient	Daily, through study completion, on average 6 months
Secondary	Acute renal failure	Number of patients with need for renal replacement therapy	Day 28
Secondary	bacterial superinfections	Number of patients with bacterial superinfections during hospitalization	Daily, through study completion, on average 6 months
Secondary	CRP levels (mg/ml)	blood tests will be taken daily during hospital stay	Daily, through study completion, on average 6 months
Secondary	prokalcitonin levels (ng/ml)	blood tests will be taken daily during hospital stay	Daily, through study completion, on average 6 months
Secondary	fibrinogen levels (g/L)	blood tests will be taken daily during hospital stay	Daily, through study completion, on average 6 months
Secondary	D-dimer levels (mg/l)	blood tests will be taken daily during hospital stay	Daily, through study completion, on average 6 months
Secondary	adverse outcomes	Number of patients with elevated serum calcium levels	Daily, through study completion, on average 6 months