RecruitingPhase 2Phase 3NCT06915701

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

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


Sponsor

University of Guadalajara

Enrollment

46 participants

Start Date

Feb 6, 2026

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria9

  • 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 Criteria11

  • 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.

Interventions

DIETARY_SUPPLEMENTWill 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.

DRUGWill 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.


Locations(2)

Civil Hospital of Guadalajara

Guadalajara, Jalisco, Mexico

Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

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NCT06915701


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