[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586463":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":50,"studyPopulation":38,"armGroups":51,"interventions":64,"overallOfficials":75,"centralContacts":79,"locations":89,"responsibleParty":118,"collaborators":120,"id":123,"slug":38,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":38,"enrollmentInfo":132,"targetDuration":38,"studyType":135,"phases":136,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":92,"whyStopped":38,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"University of Guadalajara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Levels of vitamin E","Adequacy:12 and 20 µg\u002FmL (27.9-46.4 µmol\u002FL). Insufficiency: 5 and 12 µg\u002FmL (11.6-27.9 µmol\u002FL). Minor deficiency of: 5 µg\u002FmL (11.6 µmol\u002FL).","Exchange measures: Baseline and 1 month.",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Twenty-four hour reminder \"questionnaire\" (Recommended Daily Intake of Vitamin E)","Twenty-four hour reminder:\n\nWill 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.\n\n\\> 19 years old. 15 mg daily.",{"measure":18,"description":19,"timeFrame":12},"Levels of: Proinflammatory cytokines ( IL-1β , IL-6 and TNF-α )","Units: pg\u002Fml",{"measure":21,"description":22,"timeFrame":12},"Antioxidant capacity: (DPPH, ABTS, FRAP and ORAC)","Units: μmol EQ trolox\u002FμL sample",{"measure":24,"description":25,"timeFrame":12},"Index DAS-28","Remission: \\\u003C 2.6 Low activity: 2.6 \\\u003C3.2 Moderate: 3.2 \\\u003C 5.1 High: 5.1",{"measure":27,"description":28,"timeFrame":12},"C-reactive protein (pCr)","19-49 years \\\u003C 3.33 mg\u002FL 50-64 years \\\u003C 8.50 mg\u002FL",{"measure":30,"description":31,"timeFrame":12},"Erythrocyte sedimentation rate (ESR)","20 mm\u002Fhr",{"measure":33,"description":34,"timeFrame":12},"Auto- antibodies: Anti-CCP","Positive: \\> 5 U\u002FmL Positive highs \\> 3 times cut-off value",{"measure":36,"description":37,"timeFrame":12},"Rheumatoid factor","Positive \\> 20 IU\u002FmL Positive highs \\> 3 times the cut-off value",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Definition of patients: will be patients with RA deficient in vitamin E consumption (\\\u003C15mg\u002Fday) , who are treated with conventional synthetic FARMEs (Methotrexate, Hydroxychloroquine, Leflunomide, Sulfasalazine and their combinations): The intervention group will take vitamin E 800mg\u002Fday, while the control group will take 200mg\u002Fday magnesium oxide placebo.","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":47},"DOUBLE","Placebo use:\n\nParticipants 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.\n\n\\- 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.",[48,49],"PARTICIPANT","INVESTIGATOR","Background:\n\nRheumatoid 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.\n\nα-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.\n\nVitamin 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.\n\nResearch question: Is supplementation with Vitamin E (α-tocopherol) for one month associated with decreased clinical activity and inflammation in patients with RA?\n\nSpecific objectives\n\n1. Analyze the clinical characteristics and diet quality of RA patients\n2. Determine serum autoantibody levels in RA patients\n3. Quantify serum vitamin E levels before and after supplementation in both study groups (Vitamin E and placebo)\n4. Compare clinical activity before and after supplementation in both study groups\n5. Quantify serum concentration of pro-inflammatory cytokines IL1β, IL6 and TNF-α before and after supplementation in both study groups\n6. Determine antioxidant capacity before and after supplementation in both study groups\n7. Associate vitamin E levels with clinical and inflammatory parameters of patients with RA\n\nHypothesis :\n\nThere is an association between supplementation with vitamin E (α-tocopherol) and decreased clinical activity and inflammation in patients with RA from western Mexico\n\nMethodological design:\n\na) Study type - Clinical, randomized, controlled and double-blind trial.\n\nResearch sites:\n\n* Institute of Biomedical Sciences (IICB) of the University Center for Health Sciences (CUCS)\n* Laboratory for Clinical Analysis and Translational Research (LACIT), at the University Center for Exact Sciences and Engineering (CUCEI)\n* Rheumatology Service of the Civil Hospital \"Fray Antonio Alcalde\" in Guadalajara, Jalisco.\n\nTime to develop: January 2025 to January 2027.\n\nSample size:\n\nThe 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.\n\nVariables Independent variables\n\n* Vitamin E Dependent variables\n* 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.\n\nBiosafety considerations:\n\nThis 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.\n\nEthical considerations:\n\nThe 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.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Intervention group","ACTIVE_COMPARATOR","Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg\u002Fday.",[57],"Dietary Supplement: Will take vitamin E 800mg\u002Fday",{"label":59,"type":60,"description":61,"interventionNames":62},"Control group","PLACEBO_COMPARATOR","Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg\u002Fday in placebo form.",[63],"Drug: Will take 200mg\u002Fday magnesium oxide placebo.",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":38},"DIETARY_SUPPLEMENT","Will take vitamin E 800mg\u002Fday","Patients with deficient vitamin E intake (\\\u003C15mg\u002Fday), who are treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg\u002Fday.",[53],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":38},"DRUG","Will take 200mg\u002Fday magnesium oxide placebo.","Patients with RA deficient in vitamin E intake (\\\u003C15mg\u002Fday) , who are treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg\u002Fday in placebo form.",[59],[76],{"name":77,"affiliation":5,"role":78},"Christian Johana J Baños Hernández, D.Sc.","PRINCIPAL_INVESTIGATOR",[80,85],{"name":77,"role":81,"phone":82,"phoneExt":83,"email":84},"CONTACT","+54 10585200 ó 7471493487","34200","johana.banos@academicos.udg.mx",{"name":86,"role":81,"phone":87,"phoneExt":38,"email":88},"Martin De Leon Cid, B.Nutr.","+54 4931817830","martin.deleon9901@alumnos.udg.mx",[90,111],{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Civil Hospital of Guadalajara","RECRUITING","Guadalajara","Jalisco","44280","Mexico","MX",{"type":99,"coordinates":100},"Point",[101,102],-103.34749,20.67738,{"lat":102,"lon":101},[105,108,110],{"name":106,"role":81,"phone":107,"phoneExt":83,"email":84},"Christian Johana J Baños Hernández, D.Sc","+54 10585200",{"name":109,"role":81,"phone":87,"phoneExt":38,"email":88},"Martín De León Cid, B.S. in Nutrition",{"name":106,"role":78,"phone":38,"phoneExt":38,"email":38},{"facility":112,"status":113,"city":93,"state":94,"zip":114,"country":96,"countryCode":97,"cosmosGeoPoint":115,"geoPoint":117,"contacts":38},"Universidad de Guadalajara","NOT_YET_RECRUITING","44340",{"type":99,"coordinates":116},[101,102],{"lat":102,"lon":101},{"type":119,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[121],{"name":122,"class":6},"Hospital Civil de Guadalajara","100586463",false,"NCT06915701","\"Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis\"","\"Evaluation of the Effect of Vitamin E (α-tocopherol) Supplementation on Clinical Activity and Inflammation in Patients With Rheumatoid Arthritis\"","VitE in RA","Inclusion criteria:\n\n* Female sex\n* RA classification (ACR\u002FEULAR 2010)\n* Early RA 2 years\n* Treatment with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations)\n* DAS28 ≥3.2\n* Vitamin E intake deficiency (\\\u003C15mg\u002Fday)\n* No comorbidities\n* Age \\> 18 years\n* Voluntary participation and informed consent.\n\nExclusion Criteria:\n\n* Liver and kidney disease\n* Overlap syndrome\n* Coagulation disorders\n* Pregnancy\n* 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.\n\nElimination Criteria:\n\n* Errors in administration of the 20% supplement\n* Adverse effects of the supplement\n* Pregnancy during the study\n* Insufficient blood sample\n* Voluntary withdrawal of informed consent.","FEMALE","18 Years",{"count":133,"type":134},46,"ESTIMATED","INTERVENTIONAL",[137,138],"PHASE2","PHASE3","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:\n\n* Is supplementation with vitamin E (α-tocopherol) for one month associated with decreased clinical activity and inflammation in patients with RA?\n\nResearchers 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.\n\nParticipants will:\n\n* Take two capsules (one in the morning and one in the afternoon) of either α-tocopherol or placebo every day for a month.\n* Attend clinic visits at the start of the intervention (baseline) and at the end of the month for final check-ups and tests.\n* Keep a diary to record your symptoms and how often you take α-tocopherol or placebo.",[141],"Rheumatoid Arthritis",[143,144,145],"Rheumatoid arthritis","Antioxidant","Vitamin E","2026-02-10",{"date":148,"type":149},"2026-02-13","ACTUAL",{"date":151,"type":149},"2026-02-06",{"date":153,"type":134},"2027-01-15",{"name":5,"class":6},2]