Rheumatoid Arthritis. Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention 1: intervantion group: alpha-lipoic acid 2 capsules per day- each capsule containing 600 mg alpha-lipoic acid - 0.5 hour before breakfast and dinner (every 12 hours)- for 8 weeks. Interve
Treatment - Drugs
Placebo
intervantion group: alpha-lipoic acid 2 capsules per day- each capsule containing 600 mg alpha-lipoic acid - 0.5 hour before breakfast and dinner (every 12 hours)- for 8 weeks
control group: maltodextrin 2 capsules per day- each capsule containing 600 mg maltodextrin - 0.5 hour before breakfast and dinner (every 12 hours)- for 8 weeks
Sponsors
Research Vice-chancellor of Tabriz University of Medical Sciences
Nutrition Research center of Tabriz University of Medical Science
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: female rheumatoid arthritis patients who have ACR criteria 1987 for RA; Age range of 20 to 50 years; disease activity score-2840), uncontrolled hypertension; renal failure and hepatic diseases; digestive disorders; other autoimmune and/or inflammatory disease; changing treatment protocol and lifestyle during the study; receiving antioxidant or anti-inflammatory supplements during the study; acceptance rate<75% and unwillingness to continue the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Outcomes. Timepoint: before and after intervention (8 weeks). Method of measurement: by means of DAS-28 validated questionnaire.;Serum levels of inflammatory factors (IL-6, hsCRP, TNFa). Timepoint: before and after intervention (60 days). Method of measurement: by means of special kits in Tabriz Pharmaceutical Research Center.;Serum level of matrix metalloproteinase-3 (MMP-3). Timepoint: before and after intervention (60 days). Method of measurement: by means of special kit in Tabriz Pharmaceutical Research Center.;Serum level of RF (Rheumatoid Factor). Timepoint: before and after intervention (60 days). Method of measurement: by means of special kit in Tabriz Pharmaceutical Research Center.;Serum levels of adhesion molecules: inter cellular adhesion molecule-1 (ICAM-1)and vascular cell adhesion molecule-1 (VCAM-1). Timepoint: Added at 2015-04-04: Before and after intervention (60 days). Method of measurement: Added at 2015-04-04: Using commercially available kits and ELISA method.;Added at 2015-04-29:levels of total antioxidant capacity (TAC), malondialdehyde (MDA)and arylesterase (ARE) activity in serum and superoxide dismutase (SOD)and glutathione peroxidase (GSH-Px) in whole blood. Timepoint: Added at 2015-04-29: Before and after intervention (60 days). Method of measurement: Added at 2015-04-29: TAC,SOD and GSH-Px will be measured using the spectrophotometric method by commercially available kits. MDA and ARE activity will be measured using the spectrophotometric method by chemical substances (thiobarbituric and phenylacetate respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary Intake of Energy, Nutrients. Timepoint: before and at the middle of the intervention. Method of measurement: dietary record for 3 days.;Anthropometric parameters (BMI, height, weight, waist circumference, hip circumference). Timepoint: before and after intervention (60 days). Method of measurement: Body weight without shoes with calibrated scale, Standing height without shoes, waist and hip circumferences are measured. BMI is calculated with this equation: W(kg) /H(m)2.;Systolic and diastolic blood pressure. Timepoint: before and after 8 weeks intervention. Method of measurement: by means of Mercury barometer. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Bahram Pourghassem Gargari
Health and Nutrition Faculty, Tabriz University of medical sciences
Outcome results
None listed