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

Sponsor
University of Guadalajara
Study ID
NCT06915701
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Apr 8, 2025
Start date
Feb 6, 2026
Status verified
Feb 2026
Primary completion
Dec 15, 2026
Completion
Jan 15, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention group
    Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg/day.
  • Placebo Comparator: Control group
    Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg/day in placebo form.

Primary Outcome Measure

Levels of vitamin E [ Time Frame: Exchange measures: Baseline and 1 month. ]

Central Contacts

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