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

Rheumatoid Arthritis

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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether Vitamin E (alpha-tocopherol) supplements can help reduce inflammation and disease activity in women with early-stage rheumatoid arthritis (RA) who have low Vitamin E intake. **You may be eligible if...** - You are a woman over 18 years old - You have been diagnosed with rheumatoid arthritis (RA) within the last 2 years using 2010 classification criteria - You are currently taking conventional RA medications (like methotrexate, hydroxychloroquine, or leflunomide) - Your RA is moderately to highly active (DAS28 score of 3.2 or higher) - Your daily Vitamin E intake is below 15 mg/day **You may NOT be eligible if...** - You have liver or kidney disease - You have a connective tissue overlap syndrome - You have a clotting disorder - You are pregnant - You have been taking vitamin E supplements or certain medications (including aspirin, estrogen, or cholesterol drugs) in the last 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT06915701

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