Effect of vitamin K1 supplementation in rheumatoid arthritis

Phase 2

• Conditions: Rheumatoid Arthritis.; Rheumatoid arthritis, unspecified

• Registration Number: IRCT201205203140N4
• Lead Sponsor: Vice Chancellor for Research, Nutrition and Health Faculty in Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 64

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.