A Phase 2/3 interventional study of Will take vitamin E 800mg/day and Will take 200mg/day magnesium oxide placebo. in Rheumatoid Arthritis, sponsored by University of Guadalajara. Recruiting at 2 sites in Mexico. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University of Guadalajara · Phase 2/3, Interventional, and Treatment
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:
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:
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
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:
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
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 46 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →University of Guadalajara is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Elimination Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg/day.
Dietary Supplement: Will take vitamin E 800mg/day
Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg/day in placebo form.
Drug: Will take 200mg/day magnesium oxide placebo.
Patients with deficient vitamin E intake (\<15mg/day), who are treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg/day.
Patients with RA deficient in vitamin E intake (\<15mg/day) , who are treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg/day in placebo form.
Levels of vitamin E
Adequacy:12 and 20 µg/mL (27.9-46.4 µmol/L). Insufficiency: 5 and 12 µg/mL (11.6-27.9 µmol/L). Minor deficiency of: 5 µg/mL (11.6 µmol/L).
Time frame: Exchange measures: Baseline and 1 month.
Twenty-four hour reminder "questionnaire" (Recommended Daily Intake of Vitamin E)
Twenty-four hour reminder: Will be done by the nutritionist, who will ask about the food consumed on the previous day to evaluate the quality of the diet and vitamin E consumption. The twenty-four hour reminder is a subjective method, retrospective, conducted through a face-to-face or telephone interview. This method is based on accurately remembering, describing and quantifying the food consumed one day before the consultation. All the patient's dietary intake throughout the day should be described in detail. \> 19 years old. 15 mg daily.
Time frame: Exchange measures: Baseline and 1 month.
Levels of: Proinflammatory cytokines ( IL-1β , IL-6 and TNF-α )
Units: pg/ml
Time frame: Exchange measures: Baseline and 1 month.
Antioxidant capacity: (DPPH, ABTS, FRAP and ORAC)
Units: μmol EQ trolox/μL sample
Time frame: Exchange measures: Baseline and 1 month.
Index DAS-28
Remission: \< 2.6 Low activity: 2.6 \<3.2 Moderate: 3.2 \< 5.1 High: 5.1
Time frame: Exchange measures: Baseline and 1 month.
C-reactive protein (pCr)
19-49 years \< 3.33 mg/L 50-64 years \< 8.50 mg/L
Time frame: Exchange measures: Baseline and 1 month.
Erythrocyte sedimentation rate (ESR)
20 mm/hr
Time frame: Exchange measures: Baseline and 1 month.
Auto- antibodies: Anti-CCP
Positive: \> 5 U/mL Positive highs \> 3 times cut-off value
Time frame: Exchange measures: Baseline and 1 month.
Rheumatoid factor
Positive \> 20 IU/mL Positive highs \> 3 times the cut-off value
Time frame: Exchange measures: Baseline and 1 month.
Plan to share: No — No: There is no plan to make IPD available.
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University of Guadalajara