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

NCT07412574 | Completed Early Phase 1 DMC

• 2 other identifiers: UV-CLIN-TRIAL-03418464-UV
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID - 19

Keywords

COVID-19; SARS-COV-2

Outcome Measures

Primary Outcomes (1)

• Vitamin E reduce CRP levels in COVID-19 patients

  Our findings suggest that vitamin E supplementation may significantly reduce CRP levels in COVID-19 patients

  Baseline (Day 0) and after 3 months of treatment.

Study Arms (2)

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.

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

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)

Interventions

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

α-Tocopherol (alpha-tocopherol)

Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22); Water as placebo control (Double-Blind, n =34 )

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universidad Veracruzana: lead

Study Sites (1)

Faculty of Medicine

Xalapa, Veracruz, 91120, Mexico

Location

Related Publications (3)

• 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.

  PMID: 34051548 BACKGROUND

• 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.

  PMID: 22632970 BACKGROUND

• 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.

  PMID: 32087334 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two randomized controlled trials were conducted to assess the association between vitamin E supplementation and C-reactive protein (CRP, mg/L) levels. A total of 56 patients were randomly assigned, under a double-blind design, to either the vitamin E group (n = 22) or the placebo group (n = 34). An additional 33 patients were excluded due to negative SARS-CoV-2 PCR results. Among those included in the study, 62% (34/55) were men, and 38% (21/55) were women. The intervention group received 800 IU of α-tocopherol and was compared to the placebo group to evaluate treatment-related changes in CRP levels. Statistical analysis was performed using Student's t-test with permutations, comparing dependent groups (treated vs. untreated) at baseline (day 0) and after one week of treatment.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: February 17, 2026
• Study Start: September 27, 2020
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: February 17, 2026

Record last verified: 2025-09

Locations

ME (1)