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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04525820
Recruitment Status : Active, not recruiting
First Posted : August 25, 2020
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland

Tracking Information
First Submitted Date  ICMJE August 17, 2020
First Posted Date  ICMJE August 25, 2020
Last Update Posted Date September 21, 2021
Actual Study Start Date  ICMJE December 15, 2020
Actual Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
Length of hospitalization [ Time Frame: Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19) ]
Overall duration of the hospitalization from day of admission until the day of discharge or fatality
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Need of intensive care [ Time Frame: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19) ]
    Did the patient need a intensive care treatment during the hospitalization (yes/no)
  • Lenght of the Intensive Care Treatment [ Time Frame: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19) ]
    Day of admission to ICU until discharge or fatality
  • Overall mortality [ Time Frame: During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19) ]
    Percentage of patient died during hospitalization
  • Development of vitamin D levels [ Time Frame: 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) ]
    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.
  • Development of sepsis [ Time Frame: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19) ]
    percentage of patients developing a sepsis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 24, 2020)
  • Complications due to COVID-19 [ Time Frame: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19) ]
    We assess every other complications which occurs due to COVID-19
  • Blood pressure (BP) [ Time Frame: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19) ]
    The BP will be assessed daily in mmHg
  • Heart rate [ Time Frame: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19) ]
    The heart rate will be assessed daily in bpm
  • Peripheral oxygen saturation (SpO2) [ Time Frame: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19) ]
    The SpO2 will be assessed daily in %
  • Percentage of patients who require oxygen [ Time Frame: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19) ]
    Requirement for oxygen will be assessed daily (yes/no) if yes how many liters per minute
  • Breathing frequency [ Time Frame: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19) ]
    Breathing frequence will be assessed daily in breaths per minute
  • Glasgow Coma Scale (GCS) [ Time Frame: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19) ]
    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.
  • Percentage of patients are smokers, former smokers or lifelong non-smokers [ Time Frame: Assessing of the smoking Status at Basleine ]
    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
  • Current Symptoms [ Time Frame: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19) ]
    Assessed in No/ Mild/ Moderate /Severe
  • Temperature [ Time Frame: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19) ]
    Temperature will be assessed daily in degrees celsius
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study
Official Title  ICMJE High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
one group receives a single high dose of vitamin D in addition to treatment as usual (TAU) the other group receives a single dose of placebo in addition to TAU
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The blinding is performed by the hospital pharmacy of the university hospital of Basel. They will provide us with packed and labeled study medication and placebo. They will provide us with medication packages for each patient which includes either high dose vitamin D and the standard medication or the placebo and the standard medication.
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Vitamin D Deficiency
  • Corona Virus Infection
  • ARDS
  • Coronavirus
  • SARS-CoV Infection
Intervention  ICMJE
  • 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
    Other Name: VITAMIN D3 oil 500 IU/drop
  • Drug: Placebo
    Patient receives a single dose of a placebo solution
    Other Name: Oily placebo solution
  • Drug: 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
    Other Name: Vitamin D3 solution 4000 IU/ml
Study Arms  ICMJE
  • Experimental: High Dose Vitamin D

    Patient will receive a single high dose of vitamin D (140'000) in addition to daily 800 IU of vitamin D.

    The medication be administered orally

    Interventions:
    • Drug: Single high dose vitamin D
    • Drug: Treatment as usual vitamin D
  • Placebo Comparator: Placebo
    Patient will receive a single dose of placebo, orally administered and then treatment as usual (daily 800 IU of vitamin D, orally administered)
    Interventions:
    • Drug: Placebo
    • Drug: Treatment as usual vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 24, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Actual Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04525820
Other Study ID Numbers  ICMJE 2020-01401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland
Study Sponsor  ICMJE Prof. Dr. Jörg Leuppi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jörg D Leuppi, Professor Kantonsspital Baselland
PRS Account Cantonal Hosptal, Baselland
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP