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Rheumatoid ArthritisPhase 2/3VitE in RANCT06915701

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

A Phase 2/3 study testing Will take vitamin E 800mg/day in people with Rheumatoid Arthritis, run by University of Guadalajara at 2 sites in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Will take vitamin E 800mg/day
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
2 sitesMexico
Study dates
6 Feb 2026to 15 Jan 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • No comorbidities
  • Age > 18 years
  • Voluntary participation and informed consent.

Who cannot join

  • 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:
Show all 11Show fewer
  • Errors in administration of the 20% supplement
  • Adverse effects of the supplement
  • Pregnancy during the study
  • Insufficient blood sample
  • Voluntary withdrawal of informed consent.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christian Johana J Baños Hernández, D.Sc. contact

+54 10585200 ó 7471493487 ext. 34200

johana.banos@academicos.udg.mx

Martin De Leon Cid, B.Nutr. contact

+54 4931817830

martin.deleon9901@alumnos.udg.mx

Mexico2 sites, 2 recruiting

  • Civil Hospital of Guadalajara

    Guadalajara, Jalisco, 44280

    Christian Johana J Baños Hernández, D.Sc, +54 10585200 ext. 34200, johana.banos@academicos.udg.mx

    Martín De León Cid, B.S. in Nutrition, +54 4931817830, martin.deleon9901@alumnos.udg.mx

    Recruiting

  • Universidad de Guadalajara

    Guadalajara, Jalisco, 44340

    Not yet recruiting

Other trials in Mexico

About this study

Official title: "Evaluation of the Effect of Vitamin E (α-tocopherol) Supplementation on Clinical Activity and Inflammation in Patients With Rheumatoid Arthritis"

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?
Read more

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.
Read the 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. 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

  1. Analyze the clinical characteristics and diet quality of RA patients
  2. Determine serum autoantibody levels in RA patients
  3. Quantify serum vitamin E levels before and after supplementation in both study groups (Vitamin E and placebo)
  4. Compare clinical activity before and after supplementation in both study groups
  5. Quantify serum concentration of pro-inflammatory cytokines IL1β, IL6 and TNF-α before and after supplementation in both study groups
  6. Determine antioxidant capacity before and after supplementation in both study groups
  7. 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:

  1. 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.

Being tested
Will take vitamin E 800mg/day, Will take 200mg/day magnesium oxide placebo.
Keywords
Rheumatoid arthritis, Antioxidant, Vitamin E
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Will take vitamin E 800mg/dayDietary supplement

    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.Drug

    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 groups in NCT06915701
Study groupRoleWhat they receive
Intervention groupActive comparatorTreated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg/day.
Receives: Dietary Supplement: Will take vitamin E 800mg/day
Control groupPlacebo comparatorTreated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg/day in placebo form.
Receives: Drug: Will take 200mg/day magnesium oxide placebo.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Exchange measures: Baseline and 1 month.

Secondary outcomes (8)

  1. 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.

    Measured: Exchange measures: Baseline and 1 month.

  2. Levels of: Proinflammatory cytokines ( IL-1β , IL-6 and TNF-α )

    Units: pg/ml

    Measured: Exchange measures: Baseline and 1 month.

  3. Antioxidant capacity: (DPPH, ABTS, FRAP and ORAC)

    Units: μmol EQ trolox/μL sample

    Measured: Exchange measures: Baseline and 1 month.

  4. Index DAS-28

    Remission: < 2.6 Low activity: 2.6 <3.2 Moderate: 3.2 < 5.1 High: 5.1

    Measured: Exchange measures: Baseline and 1 month.

  5. C-reactive protein (pCr)

    19-49 years < 3.33 mg/L 50-64 years < 8.50 mg/L

    Measured: Exchange measures: Baseline and 1 month.

  6. Erythrocyte sedimentation rate (ESR)

    20 mm/hr

    Measured: Exchange measures: Baseline and 1 month.

  7. Auto- antibodies: Anti-CCP

    Positive: > 5 U/mL Positive highs > 3 times cut-off value

    Measured: Exchange measures: Baseline and 1 month.

  8. Rheumatoid factor

    Positive > 20 IU/mL Positive highs > 3 times the cut-off value

    Measured: Exchange measures: Baseline and 1 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start6 Feb 2026
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Definition of patients: will be patients with RA deficient in vitamin E consumption (\<15mg/day) , who are treated with conventional synthetic FARMEs (Methotrexate, Hydroxychloroquine, Leflunomide, Sulfasalazine and their combinations): The intervention group will take vitamin E 800mg/day, while the control group will take 200mg/day magnesium oxide placebo.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915701
Sponsor's protocol ID
CEI A-176/24
Acronym
VitE in RA
Status last verified
Feb 2026
First submitted
4 Nov 2024
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No: There is no plan to make IPD available.

Publications

  • Kim KW, Kim BM, Won JY, Min HK, Lee SJ, Lee SH, Kim HR. Tocotrienol regulates osteoclastogenesis in rheumatoid arthritis. Korean J Intern Med. 2021 Mar;36(Suppl 1):S273-S282. doi: 10.3904/kjim.2019.372. Epub 2020 Jun 19.

    PubMed 32550719

  • Hama S, Kirimura N, Obara A, Takatsu H, Kogure K. Tocopheryl Phosphate Inhibits Rheumatoid Arthritis-Related Gene Expression In Vitro and Ameliorates Arthritic Symptoms in Mice. Molecules. 2022 Feb 20;27(4):1425. doi: 10.3390/molecules27041425.

    PubMed 35209214

  • Al-Okbi SY. Nutraceuticals of anti-inflammatory activity as complementary therapy for rheumatoid arthritis. Toxicol Ind Health. 2014 Sep;30(8):738-49. doi: 10.1177/0748233712462468. Epub 2012 Oct 26.

    PubMed 23104728

  • Zhang T, Yi X, Li J, Zheng X, Xu H, Liao D, Ai J. Vitamin E intake and multiple health outcomes: an umbrella review. Front Public Health. 2023 Jul 13;11:1035674. doi: 10.3389/fpubh.2023.1035674. eCollection 2023.

    PubMed 37522003

  • Glowka AK, Kowalowka M, Burchardt P, Komosa A, Kruszyna L, Andrusiewicz M, Przyslawski J, Karazniewicz-Lada M. Selected Psychosocial Factors, Nutritional Behavior, and the Analysis of Concentrations of Selected Vitamins in Patients with Cardiovascular Diseases. Nutrients. 2024 Jun 14;16(12):1866. doi: 10.3390/nu16121866.

    PubMed 38931221

  • Galli F, Azzi A, Birringer M, Cook-Mills JM, Eggersdorfer M, Frank J, Cruciani G, Lorkowski S, Ozer NK. Vitamin E: Emerging aspects and new directions. Free Radic Biol Med. 2017 Jan;102:16-36. doi: 10.1016/j.freeradbiomed.2016.09.017. Epub 2016 Nov 2.

    PubMed 27816611

  • Lewis ED, Meydani SN, Wu D. Regulatory role of vitamin E in the immune system and inflammation. IUBMB Life. 2019 Apr;71(4):487-494. doi: 10.1002/iub.1976. Epub 2018 Nov 30.

    PubMed 30501009

  • Kemnic TR, Coleman M. Vitamin E Deficiency. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519051/

    PubMed 30085593

  • Brigelius-Flohe R. Vitamin E research: Past, now and future. Free Radic Biol Med. 2021 Dec;177:381-390. doi: 10.1016/j.freeradbiomed.2021.10.029. Epub 2021 Oct 29.

    PubMed 34756995

  • Mohd Zaffarin AS, Ng SF, Ng MH, Hassan H, Alias E. Pharmacology and Pharmacokinetics of Vitamin E: Nanoformulations to Enhance Bioavailability. Int J Nanomedicine. 2020 Dec 8;15:9961-9974. doi: 10.2147/IJN.S276355. eCollection 2020.

    PubMed 33324057

  • Traber MG, Head B. Vitamin E: How much is enough, too much and why! Free Radic Biol Med. 2021 Dec;177:212-225. doi: 10.1016/j.freeradbiomed.2021.10.028. Epub 2021 Oct 23.

    PubMed 34699937

  • Mueller AL, Payandeh Z, Mohammadkhani N, Mubarak SMH, Zakeri A, Alagheband Bahrami A, Brockmueller A, Shakibaei M. Recent Advances in Understanding the Pathogenesis of Rheumatoid Arthritis: New Treatment Strategies. Cells. 2021 Nov 4;10(11):3017. doi: 10.3390/cells10113017.

    PubMed 34831240

  • Orellana C, Saevarsdottir S, Klareskog L, Karlson EW, Alfredsson L, Bengtsson C. Oral contraceptives, breastfeeding and the risk of developing rheumatoid arthritis: results from the Swedish EIRA study. Ann Rheum Dis. 2017 Nov;76(11):1845-1852. doi: 10.1136/annrheumdis-2017-211620. Epub 2017 Aug 17.

    PubMed 28818831

  • Padyukov L. Genetics of rheumatoid arthritis. Semin Immunopathol. 2022 Jan;44(1):47-62. doi: 10.1007/s00281-022-00912-0. Epub 2022 Jan 27.

    PubMed 35088123

  • Busch R, Kollnberger S, Mellins ED. HLA associations in inflammatory arthritis: emerging mechanisms and clinical implications. Nat Rev Rheumatol. 2019 Jun;15(6):364-381. doi: 10.1038/s41584-019-0219-5.

    PubMed 31092910

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Will take vitamin E 800mg/day in people with Rheumatoid Arthritis, run by University of Guadalajara at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christian Johana J Baños Hernández, D.Sc. (+54 10585200 ó 7471493487 ext. 34200, johana.banos@academicos.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of vitamin E (time frame: Exchange measures: Baseline and 1 month.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06915701, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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