N-3 PUFA and Rheumatoid Arthritis in Korea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yongsoon Park, Hanyang University
ClinicalTrials.gov Identifier:
NCT01618019
First received: June 8, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Dietary Supplement: Omega-3 fatty acid
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Hanyang University:

Primary Outcome Measures:
  • Dose of NSAID [ Time Frame: 16 week ] [ Designated as safety issue: Yes ]
    Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day


Secondary Outcome Measures:
  • Duration of Morning Stiffness [ Time Frame: 16 week ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 16 week ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 16 week ] [ Designated as safety issue: Yes ]
    Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)

  • Pain Scale [ Time Frame: 16 week ] [ Designated as safety issue: Yes ]
    Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)

  • Osteocalcin Concentration [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    serum Osteocalcin concentration as nmol/L

  • BSAP Concentration [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    serum bone specific alkaline phosphatase concentration as U/L

  • CTX Concentration [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    serum C-terminal telopeptide of type 1 collagen concentration as nmol/L


Enrollment: 109
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-3 PUFA
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
Dietary Supplement: Omega-3 fatty acid
5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
Other Name: Ropufa 75 n-3, DSM Nutritional products, Switzerland
Placebo Comparator: Placebo
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Dietary Supplement: Placebo
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618019

Locations
Korea, Republic of
Hanyang university hospital
Seoul, Korea, Republic of, 133-792
Sponsors and Collaborators
Hanyang University
Investigators
Principal Investigator: Yongsoon Park, PhD Hanyang University
  More Information

No publications provided by Hanyang University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yongsoon Park, Associate Professor, Hanyang University
ClinicalTrials.gov Identifier: NCT01618019     History of Changes
Other Study ID Numbers: HYUH-C55, KRF-2010-000-8656
Study First Received: June 8, 2012
Results First Received: June 17, 2012
Last Updated: August 30, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanyang University:
n-3 PUFA
rheumatoid arthritis
inflammation
eicosanoids
bone turnover markers

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 20, 2014