N-3 PUFA and Rheumatoid Arthritis in Korea

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Omega-3 fatty acid

• Registration Number: NCT01618019
• Lead Sponsor: Hanyang University

Brief Summary

The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid (PUFA) can be beneficial for the patients with rheumatoid arthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Results First Submitted: 2012-06-17
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-30
• Last Update Submitted: 2012-08-30
• Results First Posted: 2012-10-02
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Patients with rheumatoid arthritis diagnosed based on American College of Rheumatology guideline and receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.

Exclusion Criteria

• Patients were excluded if they were pregnant, lactating, under the age of 18 or over age 80, taking supplements containing n-3 PUFA, white blood cell (WBC) ≤ 3.5 × 109/L, hemoglobin (Hb) ≤ 8.5 g/dL, platelet ≤ 100 × 109/L, creatinine ≥ 2.0 mg/dL, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times upper limit of normal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
N-3 PUFA	Omega-3 fatty acid	5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid

Primary Outcome Measures

Name	Time	Method
Dose of NSAID	16 week	Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day

Secondary Outcome Measures

Name	Time	Method
BSAP Concentration	16 week	serum bone specific alkaline phosphatase concentration as U/L
CTX Concentration	16 week	serum C-terminal telopeptide of type 1 collagen concentration as nmol/L
Duration of Morning Stiffness	16 week	Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.
Physician's Global Assessment	16 week	Physician's global assessment is ranged from 0 to 10 by the assessing physician.; (0= no pain; 10= very severe pain)
Patient's Global Assessment	16 week	Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)
Pain Scale	16 week	Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)
Osteocalcin Concentration	16 week	serum Osteocalcin concentration as nmol/L

Trial Locations

Locations (1)

Hanyang university hospital; 🇰🇷 Seoul, Korea, Republic of