High-Dose Vitamin E (Alpha-Tocopherol) Supplementation To Reduce C-Reactive Protein In Patients With COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Vitamin E reduce CRP levels in COVID-19 patients
研究概览
简要总结
Since the first reported case of the novel coronavirus (SARS-CoV-2) in humans at the end of 2019 in Wuhan, the virus had infected approximately 100 million individuals. One year later, coronavirus disease (COVID-19) was estimated to have affected nearly 30% of the global population, with a case fatality rate of approximately 2%. In the early stages of the pandemic, numerous questions emerged regarding this novel viral agent, including its pathogenic mechanisms, associated vulnerabilities, risk factors, and potential treatment strategies. A wide spectrum of clinical conditions-including chronic diseases, infectious agents, autoimmune disorders, and even genetic or post-therapeutic alterations-can trigger inflammatory syndromes in the human body. A central component of these processes is the dysregulation of cytokine signaling, which may provoke excessive immune cell activation, leading to a self-perpetuating inflammatory loop with potentially life-threatening consequences. Notably, both SARS-CoV-2 infection and elevated C-reactive protein (CRP) levels have been consistently observed during active disease states.
Furthermore, vitamin E is well known as an antioxidant that prevents the peroxidation of lipid molecules, as ferroptosis. A well-established phenomenon is that lipid peroxidation levels are higher in COVID-19 patients, while antioxidant capacity is diminished. Therefore, the aim of this study is to evaluate CRP levels in COVID-19 patients administered high doses of vitamin E (alpha-tocopherol)-a lipid-soluble antioxidant-compared to those receiving a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both adult males and females with less than 80 yeas old in age with confirmed covid-19 infection was selected.
排除标准
- 未提供
研究组 & 干预措施
Water as placebo control (Double-Blind, n =34 )
Participants receive water administered orally as a placebo control, matching the vitamin E intervention in schedule and method of administration.
干预措施: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22) (Drug)
Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)
Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)
干预措施: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22) (Drug)
结局指标
主要结局
Vitamin E reduce CRP levels in COVID-19 patients
时间窗: Baseline (Day 0) and after 3 months of treatment.
Our findings suggest that vitamin E supplementation may significantly reduce CRP levels in COVID-19 patients
次要结局
未报告次要终点
研究者
Thuluz Meza Menchaca
Principal Investigator
Universidad Veracruzana
