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

NCT06915701 | Recruiting Phase 2 DMC

• 1 other identifier: CEI A-176/24
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Antioxidant; Vitamin E

Outcome Measures

Primary Outcomes (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).

  Exchange measures: Baseline and 1 month.

Secondary Outcomes (8)

• Twenty-four hour reminder "questionnaire" (Recommended Daily Intake of Vitamin E)

  Exchange measures: Baseline and 1 month.

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

  Exchange measures: Baseline and 1 month.

• Antioxidant capacity: (DPPH, ABTS, FRAP and ORAC)

  Exchange measures: Baseline and 1 month.

• Index DAS-28

  Exchange measures: Baseline and 1 month.

• C-reactive protein (pCr)

  Exchange measures: Baseline and 1 month.

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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.

Interventions

Will take vitamin E 800mg/day DIETARY_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.

Intervention group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead
• Civil Hospital of Guadalajara: collaborator

Study Sites (2)

Civil Hospital of Guadalajara

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

NOT YET RECRUITING

Related Publications (21)

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• 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.

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• 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.

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• 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/

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• 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.

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• 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.

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christian Johana J Baños Hernández, D.Sc.

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Johana J Baños Hernández, D.Sc.

CONTACT

+54 10585200 ó 7471493487; johana.banos@academicos.udg.mx

Martin De Leon Cid, B.Nutr.

CONTACT

+54 4931817830; martin.deleon9901@alumnos.udg.mx

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo use: Participants will be informed that they may be taking vitamin E or placebo. Both vitamin E and placebo will have similar excipients and be masked by similar packaging. \- Double blind: It is important to minimize bias in the study that both the investigators involved as well as participants should be blinded as to who is receiving the active treatment and who is receiving the placebo. After the one-month period of supplementation and data collection, the study will be opened. An independent researcher to the project will be the one who keeps the information of the double blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: April 8, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)