Status:

RECRUITING

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

Lead Sponsor:

University of Guadalajara

Collaborating Sponsors:

Civil Hospital of Guadalajara

Conditions:

Rheumatoid Arthritis

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

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 q...

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. ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 6 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 15 2027

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT06915701

Start Date

February 6 2026

End Date

January 15 2027

Last Update

February 13 2026

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Civil Hospital of Guadalajara

Guadalajara, Jalisco, Mexico, 44280

2

Universidad de Guadalajara

Guadalajara, Jalisco, Mexico, 44340