Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- In-hospital mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years.
- •COVID-19 hospitalized patients with pneumonia confirmed by chest X-ray or CT scan.
- •RT-PCR Confirmed infection with COVID-19 or strongly suspected infection with pending confirmation studies.
- •Presence of acute respiratory distress syndrome (ARDS).
- •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.
排除标准
- •Vitamin D supplementation in the previous month.
- •Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D.
- •Organ failure requiring admission to a resuscitation or high dependency unit.
- •Pregnant women.
- •Participation in another simultaneous clinical trial.
结局指标
主要结局
In-hospital mortality
时间窗: Two weeks
Death during hospitalization
Time to increase in oxygenation
时间窗: 48 hours
Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)
Duration of hospitalization
时间窗: Two weeks
Length of hospital stay
Clinical status improvement using six category ordinal scale
时间窗: 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
时间窗: Two weeks
Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge
次要结局
- Need for mechanical ventilator or intensive care unit (ICU) support(Two weeks)
- Change in C-reactive protein (CRP) levels(Two weeks)
- Occurrence of at least one severe adverse event(Two weeks)
- Change in serum ferritin levels(Two weeks)
- Occurrence of secondary infection(Two weeks)
- Change in Lactate dehydrogenase (LDH) levels(Two weeks)
研究者
Neven Sarhan
Lecturer at Faculty of Pharmacy
Misr International University