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

RecruitingPhase 2, Phase 3

Sponsor: University of Guadalajara

Conditions: Rheumatoid Arthritis

Interventions: Will take vitamin E 800mg/day, Will take 200mg/day magnesium oxide placebo.

Countries: Mexico

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* 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 Criteria:

* 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.

Locations (2)

Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico