Official Title
Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients
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.

Completed
COVID19
Corona Virus Infection
Cytokine Storm
Vitamin D Deficiency
Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Egypt
Locations

Teachers Hospital
Cairo, Please Select, Egypt

Neven Sarhan, PhD, Principal Investigator
Misr International University

Misr International University
NCT Number
Keywords
Covid-19
Cytokine storm
vitamin D
MeSH Terms
COVID-19
Coronavirus Infections
Vitamin D Deficiency
Cytokine Release Syndrome