Status:
NOT_YET_RECRUITING
"Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis"
Lead Sponsor:
University of Guadalajara
Collaborating Sponsors:
Civil Hospital of Guadalajara
Conditions:
Rheumatoid Arthritis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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 q...
Detailed Description
Background: Rheumatoid arthritis (RA) RA is one of the most common autoimmune diseases, characterized by chronic inflammation of the sinovia, mainly of the small joints of the hand, wrists and feet. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06915701
Start Date
April 28 2025
End Date
December 15 2027
Last Update
April 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Universidad de Guadalajara
Guadalajara, Jalisco, Mexico, 44340