Corona Virus Infection, Covid19, Cytokine Storm, Vitamin D Deficiency
Conditions
Keywords
COVID-19, Cytokine Storm, Vitamin D
Brief summary
Vitamin D is a secosteroid hormone which may have beneficial role in reducing COVID-19 adverse outcomes by first regulating the renin angiotensin system (RAS). Recent studies on animal in which acute respiratory distress syndrome (ARDS) was induced, showed that vitamin D lead to pulmonary permeability reduction by modulating RAS activity as well as the expression of the angiotensin-2 converting enzyme (ACE2). During COVID-19, downregulation of ACE2 leads to cytokine storm in the host, causing ARDS. In contrast, an experimental study conducted on mice in which ARDS was induced chemically, revealed that vitamin D admiration contributed to mRNA and ACE2 proteins levels improvement, ADRS milder symptoms as well as less lung damage. Additionally, vitamin D had shown antiviral effects on several previous studies, that though to be exerted either by antimicrobial peptides induction which subsequently had direct antiviral action or through immunomodulatory and anti-inflammatory effects. In addition, vitamin D stabilizes physical barriers which prevent viruses from reaching tissues susceptible to infection. Finally, previous studies demonstrated that hypovitaminosis D is accompanied by various comorbidities including diabetes mellitus, hypertension, chronic cardiovascular and respiratory diseases, and cancers, all medical conditions that are considered risk factors of COVID-19 infection deterioration and even high mortality rate. The objective of this study is to evaluate whether supplementation with high-dose vitamin D improves the prognosis of patients diagnosed with COVID-19 compared to a standard dose of vitamin D.
Interventions
None listed
Sponsors
Misr International University
Ain Shams University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 65 years. 2. COVID-19 hospitalized patients with pneumonia confirmed by chest X-ray or CT scan. 3. RT-PCR Confirmed infection with COVID-19 or strongly suspected infection with pending confirmation studies. 4. Presence of acute respiratory distress syndrome (ARDS). 5. Having either peripheral capillary oxygen saturation (SpO2) ≤ 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg.
Exclusion criteria
1. Vitamin D supplementation in the previous month. 2. Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D. 3. Organ failure requiring admission to a resuscitation or high dependency unit. 4. Pregnant women. 5. Participation in another simultaneous clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | Two weeks | Length of hospital stay |
| In-hospital mortality | Two weeks | Death during hospitalization |
| Clinical status improvement using six category ordinal scale | Two weeks | Change in six category ordinal scale. The categories were defined as follows: 1) patient discharged, 2) hospitalization not requiring supplemental oxygen, 3) hospitalization requiring supplemental low-flow oxygen, 4) hospitalization requiring high-flow supplemental oxygen, 5) hospitalization requiring invasive mechanical ventilation, 6) death. |
| Change in gas exchange | Two weeks | Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge |
| Time to increase in oxygenation | 48 hours | Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lactate dehydrogenase (LDH) levels | Two weeks | Change in levels of Lactate dehydrogenase (LDH) between baseline and before discharge |
| Need for mechanical ventilator or intensive care unit (ICU) support | Two weeks | Admission to ICU or usage of mechanical ventilator |
| Change in C-reactive protein (CRP) levels | Two weeks | Change in levels of C-reactive protein (CRP) between baseline and before discharge |
| Change in serum ferritin levels | Two weeks | Change in levels of serum ferritin between baseline and before discharge |
| Occurrence of secondary infection | Two weeks | Occurrence of sepsis |
| Occurrence of at least one severe adverse event | Two weeks | Any serious or severe adverse event that might happens during hospital stay |
Countries
Egypt
Outcome results
None listed