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Clinical Trials in Mexico / NCT06915701
Recruiting Phase 2/3

"Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis"

NCT06915701 · tracked via the Priya Life Science Mexico tracker
Sponsor
University of Guadalajara
Phase
Phase 2/3
Started
2026-02-06
Last updated
2026-02-13

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Will take vitamin E 800mg/dayWill take 200mg/day magnesium oxide placebo.

Will take vitamin E 800mg/day: 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.

Will take 200mg/day magnesium oxide placebo.: 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.

Study 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 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.

Participants will:

* Take two capsules (one in the morning and one in the afternoon) of either α-tocopherol or placebo every day for a month.
* Attend clinic visits at the start of the intervention (baseline) and at the end of the month for final check-ups and tests.
* Keep a diary to record your symptoms and how often you take α-tocopherol or placebo.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Levels of vitamin E — Exchange measures: Baseline and 1 month.
    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).

Trial sites (2)

FacilityCityRegionStatus
Civil Hospital of Guadalajara Guadalajara Jalisco Recruiting
Universidad de Guadalajara Guadalajara Jalisco Not Yet Recruiting

More University of Guadalajara trials in Mexico

Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Enrolling by invitation
Effect of Celery Seed on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Recruiting
Olive Leaf Extract, Meta-inflammation, Anxiety, and Excess Weight Enrolling by invitation
Effect of a Food Supplement with Natural Extracts of Cocoa, Amaranth Seed and Ginger in Overweight or Obese Patients Active, not recruiting
INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease) Starting soon

Other trials for the same condition

A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors) Recruiting
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate Active, not recruiting
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis Recruiting
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate Active, not recruiting
Persona Ti-Nidium Post-Market Clinical Follow-up Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06915701 on ClinicalTrials.gov ↗ ← All trials in Mexico