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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014