A Randomized, Placebo-controlled, Independent Study of the Positive, Quantifiable Effects of Sublingual Spray LYL Love Your Life® sunD3 LYLmicro™ (LYLmicro™) on Blood Levels of Vitamin D3 and Inflammatory Markers in Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Evaluating the effects of a sprayable microemulsion of cholecalciferol on vitamin D levels in the blood of COVID-19 patients
研究概览
简要总结
This placebo-controlled five-day study will be performed on 100 hospitalized COVID-19 patients with vitamin D insufficiency randomized into two groups. Vitamin D in the form of a sublingual sprayable microemulsion (LYL love your life® sunD3 LYLmicro™) is given three times daily after breakfast, lunch, and dinner (daily dose 12,000 IU) to patients with blood vitamin D levels below 30 ng/ml. The control (placebo) group recieves a placebo spray in the same daily regimen.
详细描述
This placebo-controlled five-day study will be performed on 100 hospitalized COVID-19 patients with vitamin D insufficiency randomized into two groups.
The aim of this study is to investigate the impact of the high dose vitamin D supplementation on laboratory markers of systemic inflammation such as CRP, ferritin and IL-6 in hospitalized patients with COVID-19. The blood samples are analyzed at the Joint Laboratory of the Pauls Stradins Clinical Univesity Hospital. Patients with confirmed SARS-CoV2 infection (PCR) will be randomly divided into two groups: the intervention group receives vitamin D in the form of a sublingual sprayable microemulsion (LYL love your life® sunD3 LYLmicro™) of 4,000 IU three times daily after breakfast, lunch and dinner; the control group receives the same regimen of placebo spray.
A total of 100 inpatients will be selected for the study. All patients will receive standard care for COVID-19 and existing comorbidities (diabetes, arterial hypertension, etc) according to hospital-approved protocol. The primary outcome is defined as the change in the level of the inflammatory marker and the disease's severity.
Population. Disease severity is defined by the blood oxygen saturation level. Mild clinical manifestation is characterized by SpO2≥94%, moderate 90%≤SpO2<94% and severe - SpO2<90%. Age, BMI, GFR, vitamin D and COVID-19 severity are considered as randomization parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18 and over
- •Vitamin D level below 30 ng/ml
- •Positive SARS-CoV-2 test
排除标准
- •Patients with mental health problems,
- •eGFR ≤30 ml/min,
- •Vitamin D level ≥ 30 ng/ml,
- •Pregnant women
- •Any other illness or condition that the researcher deemed may interfere with the results
- •Patients who refuse the studies
结局指标
主要结局
Evaluating the effects of a sprayable microemulsion of cholecalciferol on vitamin D levels in the blood of COVID-19 patients
时间窗: month 1-4
The study's primary outcome is to demonstrate the efficacy of sprayable microemulsion of cholecalciferol on the increase in circulating vitamin D levels over a period of at least 5 days.
次要结局
- Evaluating the effects of a sprayable microemulsion of cholecalciferol on inflammatory markers in the blood of COVID-19 patients(Month 1-4)