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.
Female sex
RA classification (ACR/EULAR 2010)
Early RA 2 years
Treatment with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations)
Liver and kidney disease
Overlap syndrome
Coagulation disorders
Pregnancy
Parallel
Will take vitamin E 800mg/day
Dietary supplementPatients 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.
Will take 200mg/day magnesium oxide placebo.
DrugPatients 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.
Levels of vitamin E
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).
Twenty-four hour reminder "questionnaire" (Recommended Daily Intake of Vitamin E)
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.
Levels of: Proinflammatory cytokines ( IL-1β , IL-6 and TNF-α )
Units: pg/ml
Antioxidant capacity: (DPPH, ABTS, FRAP and ORAC)
Units: μmol EQ trolox/μL sample
Index DAS-28
Remission: \< 2.6 Low activity: 2.6 \<3.2 Moderate: 3.2 \< 5.1 High: 5.1
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University of Guadalajara
Lead sponsor
Hospital Civil de Guadalajara
Collaborator
