A Phase 3 interventional study of cholecalciferol 200,000 IU and cholecalciferol 50,000 IU in Coronavirus, sponsored by University Hospital, Angers. Completed at 9 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University Hospital, Angers · Phase 3, Interventional, and Treatment
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator.
In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths.
Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS).
Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections.
High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status.
Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now.
We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.
Randomization is conducted on the day of the inclusion visit. The ZYMAD® 400,000 IU (2 vials of 200,000 IU) or 50,000 IU (1 vial of 50,000 IU) treatment is given to the patient.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 260 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Having at least one of the following two risk factors for complications:
Exclusion Criteria:
High dose of vitamin D3
Drug: cholecalciferol 200,000 IU
Standard dose of vitamin D3
Drug: cholecalciferol 50,000 IU
Patients receive a vitamin D supplementation of 400,000 IU in a single oral dose.
Patients receive a vitamin D supplementation of 50,000 IU in a single oral dose
Number of death of any cause, during the 14 days following the inclusion and intervention.
Time frame: Day 14
Number of death of any cause, during the 28 days following the inclusion and intervention.
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the WHO Ordinal Scale for Clinical Improvement (OSCI) for COVID-19
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 28
Rate of patients with at least one severe adverse event at day 28, according to the regulations
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
Time frame: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at baseline
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
Time frame: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
Time frame: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, depending on evolution of serum vitamin D concentration between day 0 and day 7
Time frame: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, depending on evolution of serum vitamin D concentration between day 0 and day 7
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, compared to mortality data in French hospital geriatric units from the current national survey by the French Society of Geriatrics and Gerontology
Time frame: Day 14
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University Hospital, Angers