"Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis"
Recruiting
Phase 2Phase 3Interventional Study
Rheumatoid Arthritis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
University of Guadalajara · Other
Who this trial is looking for
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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 compa…
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.
Trial Locations
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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
* A…
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.
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