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

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.

Timeline

Start

2026-02-06

Primary completion

2026-12-15

Completion

2027-01-15

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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/
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Munoz-Valle JF, Padilla-Gutierrez JR, Hernandez-Bello J, Ruiz-Noa Y, Valle Y, Palafox-Sanchez CA, Parra-Rojas I, Gutierrez-Urena SR, Rangel-Villalobos H. PTPN22 -1123G>C polymorphism and anti-cyclic citrullinated protein antibodies in rheumatoid arthritis. Med Clin (Barc). 2017 Aug 10;149(3):95-100. doi: 10.1016/j.medcli.2017.01.025. Epub 2017 Mar 11. English, Spanish.
• Background Almutairi K, Nossent J, Preen D, Keen H, Inderjeeth C. The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatol Int. 2021 May;41(5):863-877. doi: 10.1007/s00296-020-04731-0. Epub 2020 Nov 11.
• Background Moreno-Montoya J, Alvarez-Nemegyei J, Sanin LH, Perez-Barbosa L, Trejo-Valdivia B, Santana N, Goycochea-Robles MV, Cardiel MH, Riega-Torres J, Maradiaga M, Burgos-Vargas R, Pelaez-Ballestas I; GEEMA (Grupo de Estudio Epidemiologico de Enfermedades Musculo Articulares). Association of regional and cultural factors with the prevalence of rheumatoid arthritis in the Mexican population: a multilevel analysis. J Clin Rheumatol. 2015 Mar;21(2):57-62. doi: 10.1097/RHU.0000000000000223.
• Background Castillo-Canon JC, Trujillo-Caceres SJ, Bautista-Molano W, Valbuena-Garcia AM, Fernandez-Avila DG, Acuna-Merchan L. Rheumatoid arthritis in Colombia: a clinical profile and prevalence from a national registry. Clin Rheumatol. 2021 Sep;40(9):3565-3573. doi: 10.1007/s10067-021-05710-x. Epub 2021 Mar 27.
• Background Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
• Background Cush JJ. Rheumatoid Arthritis: Early Diagnosis and Treatment. Med Clin North Am. 2021 Mar;105(2):355-365. doi: 10.1016/j.mcna.2020.10.006.

Drugs

Indications