"Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis" (VitE in RA)

February 10, 2026 updated by: University of Guadalajara

"Evaluation of the Effect of Vitamin E (α-tocopherol) Supplementation on Clinical Activity and Inflammation in Patients With Rheumatoid Arthritis"

The objective of this clinical trial is to determine whether α-tocopherol (vitamin E) supplementation decreases inflammation and clinical activity in patients with rheumatoid arthritis (RA).The main questions to be answered are:

  • Is supplementation with vitamin E (α-tocopherol) for one month associated with decreased clinical activity and inflammation in patients with RA?

Researchers will compare α-tocopherol with a placebo (a look-alike substance containing no active ingredient) to see if α-tocopherol effectively reduces inflammation and clinical activity in patients with rheumatoid arthritis.

Participants will:

  • Take two capsules (one in the morning and one in the afternoon) of either α-tocopherol or placebo every day for a month.
  • Attend clinic visits at the start of the intervention (baseline) and at the end of the month for final check-ups and tests.
  • Keep a diary to record your symptoms and how often you take α-tocopherol or placebo.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Rheumatoid arthritis (RA) RA is one of the most common autoimmune diseases, characterized by chronic inflammation of the sinovia, mainly of the small joints of the hand, wrists and feet. Chronic inflammation can lead to the destruction of cartilage and joint bone, causing joint deformity, functional disability, depression and significant economic costs for the affected individual.

α-tocopherol acetate: The α-tocopherol acetate is the most widely used analogue in food supplements because of its esterification gives it stability. The main function is antioxidant preventing lipid oxidation of cell membranes for this reason α-tocopherol is considered a possible protector against diseases related to oxidative processes such as chronic diseasedegenerative diseases such as diabetes mellitus, cancer, cardiovascular disease, rheumatic disease, neurological disease and ageing.

Vitamin E in RA: The role of vitamin E as a therapy in combination with RA treatment has been studied in several studies. Studies in mouse models of laminarin-induced arthritis have shown that supplementation with α-tocopherol decreases the expression of pro-inflammatory cytokines such as IL-6, TNF-α and MMPs. However, the mechanisms involved are unknown. There are few studies in RA patients where the effect of supplementation with α-tocopherol has been analyzed. In clinical trials, it has been observed that from 3 weeks with supplementation of α-tocopherol decreases the scales of clinical activity in addition to morning stiffness and joint pain even biochemical parameters such as acute phase reactants such as pCr and ESR. However, the effect on pro-inflammatory cytokines, autoantibodies and antioxidant effect has not been analyzed.

Research question: Is supplementation with Vitamin E (α-tocopherol) for one month associated with decreased clinical activity and inflammation in patients with RA?

Specific objectives

  1. Analyze the clinical characteristics and diet quality of RA patients
  2. Determine serum autoantibody levels in RA patients
  3. Quantify serum vitamin E levels before and after supplementation in both study groups (Vitamin E and placebo)
  4. Compare clinical activity before and after supplementation in both study groups
  5. Quantify serum concentration of pro-inflammatory cytokines IL1β, IL6 and TNF-α before and after supplementation in both study groups
  6. Determine antioxidant capacity before and after supplementation in both study groups
  7. Associate vitamin E levels with clinical and inflammatory parameters of patients with RA

Hypothesis :

There is an association between supplementation with vitamin E (α-tocopherol) and decreased clinical activity and inflammation in patients with RA from western Mexico

Methodological design:

a) Study type - Clinical, randomized, controlled and double-blind trial.

Research sites:

  • Institute of Biomedical Sciences (IICB) of the University Center for Health Sciences (CUCS)
  • Laboratory for Clinical Analysis and Translational Research (LACIT), at the University Center for Exact Sciences and Engineering (CUCEI)
  • Rheumatology Service of the Civil Hospital "Fray Antonio Alcalde" in Guadalajara, Jalisco.

Time to develop: January 2025 to January 2027.

Sample size:

The statistical formula of two averages was used for the calculation of the sample size. The calculations were made with data from the corresponding 2001 clinical trial of Mona Helmy and colleagues, resulting in a sample size of 19 patients plus an increase of 20% to cover possible losses. Having 23 patients for control and intervention group. Both groups with RA of the Rheumatology Service of the Civil Hospital "Fray Antonio Alcalde" in Guadalajara, Jalisco.

Variables Independent variables

  • Vitamin E Dependent variables
  • Inflammatory cytokines (IL-1β, IL-6 and TNF-α). Antioxidant capacity:( DPPH, ABTS, FRAP and ORAC). Clinical evolution: DAS-28. Acute phase reactants: pCr and ESR. Auto-antibodies: Anti-ccp and rheumatoid factor.

Biosafety considerations:

This study will apply the guidelines set out in the Mexican Official Standards, NOM-052-SEMARNAT-2005, NOM-054-SEMARNAT-1993 and NOM-087-ECOL-SSA1-2002 that refer to classification, Handling, storage and disposal of hazardous waste, chemical reagents and biological-infectious wastes, in order to ensure the protection of people in contact with them and the environment.

Ethical considerations:

The project will be carried out in accordance with the ethical standards and principles for medical research on human beings, as set out in the Declaration of Helsinki, which were last reviewed at the 64th General Assembly, Fortaleza, Brazil, October 2013, which refers to ethical principles for medical research in humans.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Not yet recruiting
        • Universidad de Guadalajara
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Civil Hospital of Guadalajara
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Johana J Baños Hernández, D.Sc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Female sex
  • RA classification (ACR/EULAR 2010)
  • Early RA 2 years
  • Treatment with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations)
  • DAS28 ≥3.2
  • Vitamin E intake deficiency (<15mg/day)
  • No comorbidities
  • Age > 18 years
  • Voluntary participation and informed consent.

Exclusion Criteria:

  • Liver and kidney disease
  • Overlap syndrome
  • Coagulation disorders
  • Pregnancy
  • Consumption of supplements (iron, vitamin E, and K), and medications such as acetylsalicylic acid, amlodipine, estrogen, glucocorticoids and drugs used to treat dyslipidemias in the last three months.

Elimination Criteria:

  • Errors in administration of the 20% supplement
  • Adverse effects of the supplement
  • Pregnancy during the study
  • Insufficient blood sample
  • Voluntary withdrawal of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg/day.
Dietary supplement: Will take vitamin E 800mg/day
Patients with deficient vitamin E intake (<15mg/day), who are treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg/day.
Placebo Comparator: Control group
Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg/day in placebo form.
Drug: Will take 200mg/day magnesium oxide placebo.
Patients with RA deficient in vitamin E intake (<15mg/day) , who are treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg/day in placebo form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of vitamin E
Time Frame: Exchange measures: Baseline and 1 month.
Adequacy:12 and 20 µg/mL (27.9-46.4 µmol/L). Insufficiency: 5 and 12 µg/mL (11.6-27.9 µmol/L). Minor deficiency of: 5 µg/mL (11.6 µmol/L).
Exchange measures: Baseline and 1 month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Twenty-four hour reminder "questionnaire" (Recommended Daily Intake of Vitamin E)
Time Frame: Exchange measures: Baseline and 1 month.

Twenty-four hour reminder:

Will be done by the nutritionist, who will ask about the food consumed on the previous day to evaluate the quality of the diet and vitamin E consumption. The twenty-four hour reminder is a subjective method, retrospective, conducted through a face-to-face or telephone interview. This method is based on accurately remembering, describing and quantifying the food consumed one day before the consultation. All the patient's dietary intake throughout the day should be described in detail.

> 19 years old. 15 mg daily.
Exchange measures: Baseline and 1 month.
Levels of: Proinflammatory cytokines ( IL-1β , IL-6 and TNF-α )
Time Frame: Exchange measures: Baseline and 1 month.
Units: pg/ml
Exchange measures: Baseline and 1 month.
Antioxidant capacity: (DPPH, ABTS, FRAP and ORAC)
Time Frame: Exchange measures: Baseline and 1 month.
Units: μmol EQ trolox/μL sample
Exchange measures: Baseline and 1 month.
Index DAS-28
Time Frame: Exchange measures: Baseline and 1 month.
Remission: < 2.6 Low activity: 2.6 <3.2 Moderate: 3.2 < 5.1 High: 5.1
Exchange measures: Baseline and 1 month.
C-reactive protein (pCr)
Time Frame: Exchange measures: Baseline and 1 month.
19-49 years < 3.33 mg/L 50-64 years < 8.50 mg/L
Exchange measures: Baseline and 1 month.
Erythrocyte sedimentation rate (ESR)
Time Frame: Exchange measures: Baseline and 1 month.
20 mm/hr
Exchange measures: Baseline and 1 month.
Auto- antibodies: Anti-CCP
Time Frame: Exchange measures: Baseline and 1 month.
Positive: > 5 U/mL Positive highs > 3 times cut-off value
Exchange measures: Baseline and 1 month.
Rheumatoid factor
Time Frame: Exchange measures: Baseline and 1 month.
Positive > 20 IU/mL Positive highs > 3 times the cut-off value
Exchange measures: Baseline and 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Collaborators

Civil Hospital of Guadalajara

Investigators

  • Principal Investigator: Christian Johana J Baños Hernández, D.Sc., University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI A-176/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No: There is no plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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