Rheumatoid Arthritis. Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention 1: intervantion group: 10 mg vitamin K1 every day for 60 days - after a meal - chewable tablet. Intervention 2: control group: placebo every day for 60 days- chewable tablet -after a mea
Treatment - Drugs
intervantion group: 10 mg vitamin K1 every day for 60 days - after a meal - chewable tablet
control group: placebo every day for 60 days- chewable tablet -after a meal
Sponsors
Vice Chancellor for Research, Nutrition and Health Faculty in Tabriz University of Medical Sciences
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 20-50 years old; not changing the treatment protocol since 2 months prior to the study; mild to moderate disease severity. Exclusion criteria: pregnancy; lactation; postmenopausal state; receiving hormone replacement therapy; smoking or exposure to passive smoking; receiving antioxidant or anti-inflammatory supplements since 1 month prior to the study; Presence of cancer, diabetes mellitus, hormonal dysfunctions, undernutrition, severe obesity (BMI>40), uncontrolled hypertension, renal and hepatic diseases, digestion disorders, changing treatment and lifestyle, PT abnormality.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Outcomes. Timepoint: before and after intervention (60 days). Method of measurement: by means of DAS-28 validated questionnaire.;Serum levels of 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 RF (Rheumatoid Factor). Timepoint: before and after intervention (60 days). Method of measurement: by means of special kit in Tabriz Pharmaceutical Research Center.;Lipid profile (TC,TG,HDL,LDL). Timepoint: before and after intervention (60 days). Method of measurement: all parameters as HDL-C- Total cholesterol- triglyceride with enzymatic kits except LDL-c ( by means of Friedwald formula).;Serum level of matrix metalloproteinases-3 (MMP-3). Timepoint: before and after intervention (60 days). Method of measurement: by means of special kit in Tabriz Pharmaceutical Research Center. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary Intake of Energy, Nutrients and Comparison with RDA. Timepoint: before and after intervention (60 days). Method of measurement: dietary record for 3 days.;Anthropometric indicator (BMI). Timepoint: before and after intervention (60 days). Method of measurement: Body weight without shoes with calibrated scale, Standing height without shoes are measuredl. BMI was calculated with this equation: W(kg) /H(m)2. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Bahram Pourghassem Gargari
Health and Nutrition Faculty, Tabriz University of medical sciences
Outcome results
None listed