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New treatment option for Rheumatoid Arthritis
Official title "Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis"
ClinicalTrials.gov ID: NCT06915701
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- Errors in administration of the 20% supplement
See the full eligibility 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.
- 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...
- Errors in administration of the 20% supplement
- Adverse effects of the supplement
- Pregnancy during the study
- Insufficient blood sample
- Voluntary withdrawal of informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Guadalajara, Jalisco, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guadalajara, Jalisco, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.