Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
FEMALE
ID06915701

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

Led by University of Guadalajara · Updated on 2026-02-13

46

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Guadalajara

Lead Sponsor

H

Hospital Civil de Guadalajara

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to determine whether supplementation with vitamin E (alpha-tocopherol) reduces inflammation and clinical activity in patients with rheumatoid arthritis (RA). RA is a common autoimmune disease causing chronic joint inflammation and potential joint damage, which leads to disability and affects quality of life. The study focuses on patients with early RA who have low vitamin E intake and are already receiving standard RA treatments. Participants will be randomly assigned to one of two groups: one group will receive conventional synthetic disease-modifying antirheumatic drugs (FARMEs) plus 800 mg per day of vitamin E, while the other group will receive the same FARMEs plus a 200 mg per day magnesium oxide placebo. The supplementation lasts for one month, with participants taking two capsules daily, one in the morning and one in the afternoon. During the study, participants will attend clinic visits at the start and end of the supplementation period for assessments including clinical activity, blood tests measuring vitamin E levels, inflammatory markers, autoantibodies, and antioxidant capacity. They will keep a diary to track symptoms and supplement intake. Researchers will evaluate changes in vitamin E levels, clinical disease activity (DAS-28), pro-inflammatory cytokines, acute phase reactants, and autoantibodies to understand the impact of vitamin E supplementation on RA.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Diagnosis of rheumatoid arthritis according to ACR/EULAR 2010 criteria
  • Early rheumatoid arthritis for 2 years or less
  • Treatment with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina, or their combinations)
  • Disease Activity Score (DAS28) of 3.2 or higher
  • Vitamin E intake less than 15 mg per day
  • No other comorbidities
  • Age over 18 years
  • Voluntary participation with informed consent
Not Eligible

You will not qualify if you...

  • Liver or kidney disease
  • Overlap syndrome
  • Coagulation disorders
  • Pregnancy
  • Use of supplements like iron, vitamin E, or vitamin K in the last three months
  • Use of medications such as acetylsalicylic acid, amlodipine, estrogen, glucocorticoids, or drugs for dyslipidemia in the last three months
  • Errors in supplement administration
  • Adverse effects from the supplement
  • Pregnancy during the study
  • Insufficient blood sample
  • Voluntary withdrawal of consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 1 month

Participants take either vitamin E 800mg/day or a placebo (magnesium oxide 200mg/day) alongside their conventional rheumatoid arthritis medications to study the effect on clinical activity and inflammation.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 2 locations

1

Civil Hospital of Guadalajara

Guadalajara, Jalisco, Mexico, 44280

Actively Recruiting

2

Universidad de Guadalajara

Guadalajara, Jalisco, Mexico, 44340

Not Yet Recruiting

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Research Team

C

Christian Johana J Baños Hernández, D.Sc.

M

Martin De Leon Cid, B.Nutr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Tocopheryl Phosphate Inhibits Rheumatoid Arthritis-Related Gene Expression In Vitro and Ameliorates Arthritic Symptoms in Mice.

Susumu Hama, Naoko Kirimura, Aki Obara...

https://pubmed.ncbi.nlm.nih.gov/35209214

Selected Psychosocial Factors, Nutritional Behavior, and the Analysis of Concentrations of Selected Vitamins in Patients with Cardiovascular Diseases.

Anna Krystyna Główka, Magdalena Kowalówka, Paweł Burchardt...

https://pubmed.ncbi.nlm.nih.gov/38931221