High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study

Covid19 Clinical Trial

— VitCov  

Official title:

High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525820
• Other study ID #: 2020-01401
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2023
• Source: Cantonal Hosptal, Baselland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.

Description:

The world is currently experiencing a coronavirus (SARS-CoV-2) pandemic. The disease caused by infection with this virus is known as COVID-19. Risk factors for a poor outcome of COVID-19 have so far been found to include, older age and co-morbidity including chronic respiratory conditions and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. 25-hydroxyvitamin D supports induction of antimicrobial peptides in response to both viral and bacterial stimuli suggesting a potential mechanism by which vitamin D inducible protection against respiratory pathogens might be mediated. The clear functions of vitamin D in the immune system are difficult to define because the immune response is not a static process. The vitamin-D-receptor, which has also been detected in immunological cells, suggests that vitamin D can regulate some processes related to immunity. A further argument which supports a potential antiviral activity of vitamin D is the modulation of the inflammatory response. The release of pro-inflammatory cytokines by the influenza virus appeared to correlate with the severity of illness. The use of vitamin D as a prophylactic for influenza has shown promise in prevention of illness and reduction of secondary asthma in children. Inadequate vitamin D status is associated with susceptibility to upper respiratory infections in patients with chronic obstructive pulmonary disease (COPD). In the ViDiCo-trial vitamin D supplementation protected against moderate or severe exacerbation, but not upper respiratory infection, in patients with COPD. A further study retrospectively examined data from 108 patients with acute respiratory distress syndrome (ARDS) for whom a vitamin D status was available at the time of diagnosis revealed that over 95% of these patients had vitamin D deficiency. When examined according to quarterly of serum 25- hydroxyvitamin D, a consistent inverse relationship between serum 25-hydroxyvitamin D and length of hospital and ICU stay among survivors was observed. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. For this purpose the investigators designed a randomized, placebo controlled double blind trial to test the hypothesis hypothesis that a single high dose of vitamin D in addition to standard treatment improves the recovery period positively in patients with COVID-19 and vitamin D deficiency compared to standard treatment only. That means, that the time of recovery is shorter in the single high dose vitamin D group relative to standard treatment group only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature
• Hospitalized Patient
• Ongoing COVID-19 infection
• Vitamin D deficiency defined as a serum 25-hydroxyvitamin D concentration = 50nmol/l( =20ng/ml)
• > 18 years of age

Exclusion Criteria:

• Known hypersensitivity to one of the used products of vitamin D or indigents in the drug's composition
• Active malignancy
• Hypercalcemia
• Granulomatous disease such as sarcoidosis
• History of renal stones within the past year
• Pregnancy/breastfeeding, as evaluated through screening,
• Previous enrollment into the current study,
• Enrollment of the investigator, his/her family members, employees and other dependent persons,

Related Conditions & MeSH terms

• ARDS
• Communicable Diseases
• Corona Virus Infection
• Coronavirus
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Vitamin D Deficiency

Intervention

Drug:
• Single high dose vitamin D
Patient receives either one dose orally of 140'000 IU (7 ml) of this drug once as an intervention treatment additionally to TAU or the patient receives 7 ml of the placebo Solution (7 ml) in addition to TAU
• Placebo
Patient receives a single dose of a placebo solution
• Treatment as usual vitamin D
Both groups receive the treatment as usual after the single high dose or the placebo which will be 800 IU per day

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Baselland Liestal	Liestal	BL
Switzerland	Cantonal Hospital St. Gallen	Saint Gallen	SG

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Jörg Leuppi

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications due to COVID-19	We assess every other complications which occurs due to COVID-19	During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)
Other	Blood pressure (BP)	The BP will be assessed daily in mmHg	Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)
Other	Heart rate	The heart rate will be assessed daily in bpm	Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)
Other	Peripheral oxygen saturation (SpO2)	The SpO2 will be assessed daily in %	Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)
Other	Percentage of patients who require oxygen	Requirement for oxygen will be assessed daily (yes/no) if yes how many liters per minute	Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)
Other	Breathing frequency	Breathing frequence will be assessed daily in breaths per minute	Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)
Other	Glasgow Coma Scale (GCS)	GCS will be assessed daily 3 to 15 points. It describes the extent of impaired consciousness. 15 points means no impairment, 3 points means severe impairment of consciousness.	Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)
Other	Percentage of patients are smokers, former smokers or lifelong non-smokers	Assessing the history of smoking in pack years (PY). the assessment will be made with the following options for answering Current smoker: Smoking for how many years? Cigarettes per day? Former smoker, how many years smoked? How many cigarettes per day Life-long non-smoker	Assessing of the smoking Status at Basleine
Other	Current Symptoms	Assessed in No/ Mild/ Moderate /Severe	Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)
Other	Temperature	Temperature will be assessed daily in degrees celsius	Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)
Primary	Length of hospitalization	Overall duration of the hospitalization from day of admission until the day of discharge or fatality	Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)
Secondary	Need of intensive care	Did the patient need a intensive care treatment during the hospitalization (yes/no)	Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)
Secondary	Lenght of the Intensive Care Treatment	Day of admission to ICU until discharge or fatality	Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)
Secondary	Overall mortality	Percentage of patient died during hospitalization	During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19)
Secondary	Development of vitamin D levels	percentage of patients with 25-hydroxyvitamin D > 50nmol/L (>20ng/mL) at day 7; - The values of calcium, phosphorus, 24-hydroxyvitamin D, 1.25-dihydroxyvitamin D, parathyroid hormone.	Day 1 (Baseline) and Day 7 after the first administration of the high dose vitamin D or the placebo and at discharge (mean hospital stay is between 14 and 22 days for Patients with COVID-19)
Secondary	Development of sepsis	percentage of patients developing a sepsis	During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)