COVID - 19Early Phase 1VITECNCT07412574
Vitamin E Supplementation As Adjunctive Therapy To Lower Inflammation In COVID-19 Patients
A Early Phase 1 study testing Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22) in people with COVID - 19, run by Universidad Veracruzana at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID - 19
- What is being tested?
- Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteMexico
- Study dates
- 27 Sep 2020to 27 Sep 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Both adult males and females with less than 80 yeas old in age with confirmed covid-19 infection was selected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID - 19
- Being tested
- Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)
- Keywords
- COVID-19, SARS-COV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)Drug
α-Tocopherol (alpha-tocopherol)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Day 0) and after 3 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start27 Sep 2020
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Veracruzana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thuluz Meza Menchaca, Universidad Veracruzana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412574
- Sponsor's protocol ID
- UV-CLIN-TRIAL-034
- Other IDs
- 18464-UV
- Acronym
- VITEC
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Publications
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.
PubMed 34051548Dixon 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.
PubMed 22632970Li 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.
PubMed 32087334
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Vitamin E (Alpha-Tocopherol) Supplementation To Reduce C-Reactive Protein In Patients With COVID-19
- ClinicalTrials.gov ID
- NCT07412574
- Acronym / sponsor ID
- VITEC / UV-CLIN-TRIAL-034
- Conditions
- COVID - 19
- Keywords
- COVID-19, SARS-COV-2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universidad VeracruzanaUniversity, hospital or other
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Water as placebo control (Double-Blind, n =34 ) | Placebo comparator | Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)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) | 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22)α-Tocopherol (alpha-tocopherol) | Drug | Drug: Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22), Water as placebo control (Double-Blind, n =34 ) |
Primary outcome
Vitamin E reduce CRP levels in COVID-19 patients
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 34051548Leggat 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.
- Background: PubMed 22632970Dixon 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.
- Background: PubMed 32087334Li 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.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Patients were randomly assigned, under a double-blind design, α-Tocopherol group (n = 22) in people with COVID - 19, run by Universidad Veracruzana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin E reduce CRP levels in COVID-19 patients (time frame: Baseline (Day 0) and after 3 months of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07412574, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.