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Clinical Trials/NCT01618019
NCT01618019
Completed
Not Applicable

Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis

Hanyang University1 site in 1 country109 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Hanyang University
Enrollment
109
Locations
1
Primary Endpoint
Dose of NSAID
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
December 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yongsoon Park

Associate Professor

Hanyang University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Dose of NSAID

Time Frame: 16 week

Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day

Secondary Outcomes

  • BSAP Concentration(16 week)
  • CTX Concentration(16 week)
  • Duration of Morning Stiffness(16 week)
  • Physician's Global Assessment(16 week)
  • Patient's Global Assessment(16 week)
  • Pain Scale(16 week)
  • Osteocalcin Concentration(16 week)

Study Sites (1)

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