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

Not Applicable

• Conditions: Respiratory Distress Syndrome; Vitamin D Deficiency; Covid-19
• Interventions: Dietary Supplement: cholecalciferol

• Registration Number: NCT05384574
• Lead Sponsor: University Hospital of Split

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-22
• Status Verified: 2022-05
• Primary Completion: 2022-05
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-20
• Last Update Posted: 2022-05-20
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	cholecalciferol	Patients with low levels of Vitamin D on admission to ICU randomized to receive vitamin D supplementation

Primary Outcome Measures

Name	Time	Method
number of days on mechanical ventilation	Daily, through study completion, on average 6 months	Number of days spent on mechanical ventilation for each patient

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Split; 🇭🇷 Split, Croatia