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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Guadalajara

About this trial

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 criteria

Qualifiers

Female sex

RA classification (ACR/EULAR 2010)

Early RA 2 years

Treatment with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations)

Disqualifiers

Liver and kidney disease

Overlap syndrome

Coagulation disorders

Pregnancy

Trial design

Treatments tested in this trial

  • Will take vitamin E 800mg/day
  • Will take 200mg/day magnesium oxide placebo.

Treatment groups

46 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Guadalajara

Lead sponsor

Hospital Civil de Guadalajara

Collaborator