Vitamin E (α-tocopherol) to reduce inflammation and symptoms in rheumatoid arthritis

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

This project will test whether taking vitamin E every day for one month reduces inflammation and joint symptoms in adults with early rheumatoid arthritis who have low vitamin E intake.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Guadalajara (other)
• Locations: 2 sites (Guadalajara, Jalisco and 1 other locations)
• Trial ID: NCT06915701 on ClinicalTrials.gov

What this trial studies

Adults with early rheumatoid arthritis who meet eligibility criteria will be assigned to take either 800 mg/day α-tocopherol (two capsules) or a matching placebo for one month while continuing their conventional synthetic disease-modifying drugs. Clinic visits are scheduled at baseline and after one month for clinical exams and blood tests, and participants will keep a daily symptom and dosing diary. The main outcomes are changes in clinical disease activity (DAS28) and inflammatory markers. The trial is conducted at the University of Guadalajara and the Civil Hospital of Guadalajara.

Who should consider this trial

Good fit: Adult women with early (≤2 years) rheumatoid arthritis, active disease (DAS28 ≥ 3.2), low dietary vitamin E intake (<15 mg/day), on conventional synthetic DMARD therapy, without comorbidities, and willing to consent are ideal candidates.

Not a fit: Men, patients with significant comorbidities, those already taking vitamin E or excluded medications or supplements, pregnant individuals, and people with longer-standing or more complex RA are unlikely to benefit from this specific protocol.

Why it matters

Potential benefit: If effective, short-term vitamin E supplementation could lower joint inflammation and disease activity, improving symptoms for some patients with early rheumatoid arthritis.

How similar studies have performed: Animal studies and a few small clinical trials have reported reductions in inflammatory markers and clinical activity with α-tocopherol, but overall human evidence is limited and mechanisms remain unclear.

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.

Where this trial is running

Guadalajara, Jalisco and 1 other locations

• Civil Hospital of Guadalajara — Guadalajara, Jalisco, Mexico (RECRUITING)
• Universidad de Guadalajara — Guadalajara, Jalisco, Mexico (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Christian Johana J Baños Hernández, D.Sc. — University of Guadalajara
• Study coordinator: Christian Johana J Baños Hernández, D.Sc.

Conditions: Rheumatoid Arthritis, Rheumatoid arthritis, Antioxidant, Vitamin E