- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07412574
Vitamin E Supplementation As Adjunctive Therapy To Lower Inflammation In COVID-19 Patients (VITEC)
High-Dose Vitamin E (Alpha-Tocopherol) Supplementation To Reduce C-Reactive Protein In Patients With COVID-19
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Veracruz
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Xalapa, Veracruz, Mexico, 91120
- Faculty of medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: 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.
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α-Tocopherol (alpha-tocopherol)
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Experimental: Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)
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α-Tocopherol (alpha-tocopherol)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vitamin E reduce CRP levels in COVID-19 patients
Time Frame: Baseline (Day 0) and after 3 months of treatment.
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Our findings suggest that vitamin E supplementation may significantly reduce CRP levels in COVID-19 patients
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Baseline (Day 0) and after 3 months of treatment.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Dixon SJ, Lemberg KM, Lamprecht MR, Skouta R, Zaitsev EM, Gleason CE, Patel DN, Bauer AJ, Cantley AM, Yang WS, Morrison B 3rd, Stockwell BR. Ferroptosis: an iron-dependent form of nonapoptotic cell death. Cell. 2012 May 25;149(5):1060-72. doi: 10.1016/j.cell.2012.03.042.
- Leggat G, Livingston M, Kuntsche S, Callinan S. Changes in alcohol consumption during pregnancy and over the transition towards parenthood. Drug Alcohol Depend. 2021 Aug 1;225:108745. doi: 10.1016/j.drugalcdep.2021.108745. Epub 2021 May 21.
- Li JY, You Z, Wang Q, Zhou ZJ, Qiu Y, Luo R, Ge XY. The epidemic of 2019-novel-coronavirus (2019-nCoV) pneumonia and insights for emerging infectious diseases in the future. Microbes Infect. 2020 Mar;22(2):80-85. doi: 10.1016/j.micinf.2020.02.002. Epub 2020 Feb 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UV-CLIN-TRIAL-034
- 18464-UV (Other Identifier: University of Veracruz)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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