Vitamin E Supplementation As Adjunctive Therapy To Lower Inflammation In COVID-19 Patients (VITEC)

Universidad Veracruzana

Status and phase: Completed; Early Phase 1

Conditions: COVID - 19

Treatments: Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)

Study type: Interventional

Funder types: Other

Identifiers

NCT07412574

18464-UV (Other Identifier)

UV-CLIN-TRIAL-034

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Both adult males and females with less than 80 yeas old in age with confirmed covid-19 infection was selected.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Water as placebo control (Double-Blind, n =34 )

Placebo Comparator group

Description:

Participants receive water administered orally as a placebo control, matching the vitamin E intervention in schedule and method of administration.

Treatment:

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)

Experimental group

Description:

Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)

Treatment:

Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)