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临床试验/NCT07412574
NCT07412574已完成1 期

High-Dose Vitamin E (Alpha-Tocopherol) Supplementation To Reduce C-Reactive Protein In Patients With COVID-19

Universidad Veracruzana1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年9月27日最近更新:
干预措施

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

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 )

Placebo Comparator

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)

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thuluz Meza Menchaca

Principal Investigator

Universidad Veracruzana

研究点 (1)

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