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IRCT138901183655N1 IRCT 2010-06-22 Research Vice- Chancellor of Nutrition and Health Faculty in Tabriz University of Medical Sciences The Effect of Selenplus on Rheumatoid Arthritis The Effect of Combined Antioxidant Supplementation on Blood Antioxidants indices, Lipid Peroxidation, Lipid Profile and Clinical Outcomes in Female Patients with Rheumatoid Arthritis 2010-06-22 anticipated 40 Complete https://irct.ir/trial/3734 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: In the design of this study, confounding factors such as: dietary intake of foods and nutrients, body mass index and emotional stress level will be measured before and after the antioxidant intervention for adjusting the relationship of these variables with study outcomes. N/A Rheumatoid Arthritis. Selenplus capsule(Eurovital company of Germany): Selenium 50mcg, Zinc 8mg, Vitamin A 400mcg, Vitamin C125mg, Vitamin E 40mg daily for 3 month duration.
public Dr Seyed Rafi Arefhosseini
Nutrition and Health Faculty- Attar-e- Neishabori avenue- Golgasht avenue- Tabriz
Tabriz Iran (Islamic Republic of) +98 41 1335 7580 arefhosseinir@tbzmed.ac.ir Nutrition and Health Faculty in Tabriz University of Medical Sciences scientific Dr Seyed Rafi Arefhosseini
Nutrition and Health Faculty- Attar-e- Neishabori avenue- Golgasht avenue- Tabriz
Tabriz Iran (Islamic Republic of) +98 41 1335 7580 arefhosseinir@tbzmed.ac.ir Health and Nutrition Faculty in Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: female rheumatoid arthritis patients who have ACR criteria 1987 for RA, age 40-60 yrs old, not changing the treatment protocol since 2 months prior to the study, mild to moderate disease severity, Exclusion criteria: Presence of diabetes mellitus, hypertension, thyroid dysfunction, renal diseases, hepatic disorders, or Cushing’s syndrome, smoking or exposure to passive smoking, changing treatment and drugs, receiving antioxidant supplements 40 years 60 years Female M06.9 Rheumatoid arthritis, unspecified Treatment - Drugs Selenplus capsule(Eurovital company of Germany): Selenium 50mcg, Zinc 8mg, Vitamin A 400mcg, Vitamin C125mg, Vitamin E 40mg daily for 3 month duration Blood Antioxidant Indices. Timepoint: twice: before and after 3 months. Method of measurement: all of parameters(superoxide dismutase, glutathione peroxidase, catalase, Total antioxidant capacity) by means of enzymatic kits except for catalase(with chemical substances) in Tabriz Pharmaceutical Research Center. Clinical Outcomes. Timepoint: twice: before and after 3 months. Method of measurement: by means of DAS-28 validated questionnaire. Lipid Profile. Timepoint: twice: before and after 3 months. Method of measurement: all parameters as HDL-C- Total cholesterol- triglyceride with enzymatic kits except LDL-c ( by means of Friedwald formula). Lipid Peroxidation. Timepoint: twice: before and after 3 months. Method of measurement: by chemical substances in Tabriz Pharmaceutical Research Center. Serum Arylesterase Enzyme. Timepoint: twice: before and after 3 months. Method of measurement: by chemical substances in Tabriz Pharmaceutical Research Center. Emotional Stress Level. Timepoint: twice: before and after 3 months. Method of measurement: by validated emotional stress questionnaire- assissted by MSc psychology practioner. Dietary Intake of Energy, Nutrients and Comparison with RDA. Timepoint: twice: before and after 3 months. Method of measurement: by validated dietary questionnaires: FFQ and 24- hr recall questionnaire for 3 days- calculated by Nutritionist 3 software. Weight. Timepoint: twice: before and after 3 months. Method of measurement: weighed by digital scales with 0.1 kg sensitivity. Body Mass Index (BMI). Timepoint: twice: before and after 3 months. Method of measurement: calculated with Quetlet's formula(weight(kg)/(height*height(m))). Rheumatology Research, Faculty of Medicine, Tabriz University of Medical Sciences Research Vice- Chancellor of Nutrition and Health Faculty in Tabriz University of Medical Sciences Rheumatology Research, Faculty of Medicine, Tabriz University of Medical Sciences Approved 2010-07-06 Research Vice- Chancellor of Tabriz University of Medical Sciences Research Vice- Chancellor of Tabriz University of Medical sciences, Attar-e-Neishabori avenue, Golgasht avenue, Tabriz Tabriz Iran (Islamic Republic of)