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. Chronic inflammation can lead to the destruction of cartilage and joint bone,
causing joint deformity, functional disability, depression and significant economic costs
for the affected individual.
α-tocopherol acetate: The α-tocopherol acetate is the most widely used analogue in food
supplements because of its esterification gives it stability. The main function is
antioxidant preventing lipid oxidation of cell membranes for this reason α-tocopherol is
considered a possible protector against diseases related to oxidative processes such as
chronic diseasedegenerative diseases such as diabetes mellitus, cancer, cardiovascular
disease, rheumatic disease, neurological disease and ageing.
Vitamin E in RA: The role of vitamin E as a therapy in combination with RA treatment has
been studied in several studies. Studies in mouse models of laminarin-induced arthritis
have shown that supplementation with α-tocopherol decreases the expression of
pro-inflammatory cytokines such as IL-6, TNF-α and MMPs. However, the mechanisms involved
are unknown. There are few studies in RA patients where the effect of supplementation
with α-tocopherol has been analyzed. In clinical trials, it has been observed that from 3
weeks with supplementation of α-tocopherol decreases the scales of clinical activity in
addition to morning stiffness and joint pain even biochemical parameters such as acute
phase reactants such as pCr and ESR. However, the effect on pro-inflammatory cytokines,
autoantibodies and antioxidant effect has not been analyzed.
Research question: Is supplementation with Vitamin E (α-tocopherol) for one month
associated with decreased clinical activity and inflammation in patients with RA?
Specific objectives
Analyze the clinical characteristics and diet quality of RA patients
Determine serum autoantibody levels in RA patients
Quantify serum vitamin E levels before and after supplementation in both study
groups (Vitamin E and placebo)
Compare clinical activity before and after supplementation in both study groups
Quantify serum concentration of pro-inflammatory cytokines IL1β, IL6 and TNF-α
before and after supplementation in both study groups
Determine antioxidant capacity before and after supplementation in both study groups
Associate vitamin E levels with clinical and inflammatory parameters of patients
with RA
Hypothesis :
There is an association between supplementation with vitamin E (α-tocopherol) and
decreased clinical activity and inflammation in patients with RA from western Mexico
Methodological design:
a) Study type - Clinical, randomized, controlled and double-blind trial.
Research sites:
Institute of Biomedical Sciences (IICB) of the University Center for Health Sciences
(CUCS)
Laboratory for Clinical Analysis and Translational Research (LACIT), at the
University Center for Exact Sciences and Engineering (CUCEI)
Rheumatology Service of the Civil Hospital "Fray Antonio Alcalde" in Guadalajara,
Jalisco.
Time to develop: January 2025 to January 2027.
Sample size:
The statistical formula of two averages was used for the calculation of the sample size.
The calculations were made with data from the corresponding 2001 clinical trial of Mona
Helmy and colleagues, resulting in a sample size of 19 patients plus an increase of 20%
to cover possible losses. Having 23 patients for control and intervention group. Both
groups with RA of the Rheumatology Service of the Civil Hospital "Fray Antonio Alcalde"
in Guadalajara, Jalisco.
Variables Independent variables
Vitamin E Dependent variables
Inflammatory cytokines (IL-1β, IL-6 and TNF-α). Antioxidant capacity:( DPPH, ABTS,
FRAP and ORAC). Clinical evolution: DAS-28. Acute phase reactants: pCr and ESR.
Auto-antibodies: Anti-ccp and rheumatoid factor.
Biosafety considerations:
This study will apply the guidelines set out in the Mexican Official Standards,
NOM-052-SEMARNAT-2005, NOM-054-SEMARNAT-1993 and NOM-087-ECOL-SSA1-2002 that refer to
classification, Handling, storage and disposal of hazardous waste, chemical reagents and
biological-infectious wastes, in order to ensure the protection of people in contact with
them and the environment.
Ethical considerations:
The project will be carried out in accordance with the ethical standards and principles
for medical research on human beings, as set out in the Declaration of Helsinki, which
were last reviewed at the 64th General Assembly, Fortaleza, Brazil, October 2013, which
refers to ethical principles for medical research in humans.
