Tocotrienol regulates osteoclastogenesis in rheumatoid arthritis.
Kyoung-Woon Kim, Bo-Mi Kim, Ji-Yeon Won...
https://pubmed.ncbi.nlm.nih.gov/32550719Actively Recruiting
Led by University of Guadalajara · Updated on 2026-02-13
46
Participants Needed
2
Research Sites
4 weeks
Total Duration
U
University of Guadalajara
Lead Sponsor
H
Hospital Civil de Guadalajara
Collaborating Sponsor
This research aims to determine whether supplementation with vitamin E (alpha-tocopherol) reduces inflammation and clinical activity in patients with rheumatoid arthritis (RA). RA is a common autoimmune disease causing chronic joint inflammation and potential joint damage, which leads to disability and affects quality of life. The study focuses on patients with early RA who have low vitamin E intake and are already receiving standard RA treatments. Participants will be randomly assigned to one of two groups: one group will receive conventional synthetic disease-modifying antirheumatic drugs (FARMEs) plus 800 mg per day of vitamin E, while the other group will receive the same FARMEs plus a 200 mg per day magnesium oxide placebo. The supplementation lasts for one month, with participants taking two capsules daily, one in the morning and one in the afternoon. During the study, participants will attend clinic visits at the start and end of the supplementation period for assessments including clinical activity, blood tests measuring vitamin E levels, inflammatory markers, autoantibodies, and antioxidant capacity. They will keep a diary to track symptoms and supplement intake. Researchers will evaluate changes in vitamin E levels, clinical disease activity (DAS-28), pro-inflammatory cytokines, acute phase reactants, and autoantibodies to understand the impact of vitamin E supplementation on RA.
CONDITIONS
"Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis"
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 month
Participants take either vitamin E 800mg/day or a placebo (magnesium oxide 200mg/day) alongside their conventional rheumatoid arthritis medications to study the effect on clinical activity and inflammation.
1 baseline visit and 1 follow-up visit
Total: 2 locations
1
Civil Hospital of Guadalajara
Guadalajara, Jalisco, Mexico, 44280
Actively Recruiting
2
Universidad de Guadalajara
Guadalajara, Jalisco, Mexico, 44340
Not Yet Recruiting
C
Christian Johana J Baños Hernández, D.Sc.
M
Martin De Leon Cid, B.Nutr.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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