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N-3 PUFA and Rheumatoid Arthritis in Korea

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ClinicalTrials.gov Identifier: NCT01618019
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : October 2, 2012
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Yongsoon Park, 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Dietary Supplement: Omega-3 fatty acid Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis
Study Start Date : November 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Dose of NSAID [ Time Frame: 16 week ]
    Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day


Secondary Outcome Measures :
  1. Duration of Morning Stiffness [ Time Frame: 16 week ]
    Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.

  2. Physician's Global Assessment [ Time Frame: 16 week ]

    Physician's global assessment is ranged from 0 to 10 by the assessing physician.

    (0= no pain; 10= very severe pain)


  3. Patient's Global Assessment [ Time Frame: 16 week ]
    Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)

  4. Pain Scale [ Time Frame: 16 week ]
    Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)

  5. Osteocalcin Concentration [ Time Frame: 16 week ]
    serum Osteocalcin concentration as nmol/L

  6. BSAP Concentration [ Time Frame: 16 week ]
    serum bone specific alkaline phosphatase concentration as U/L

  7. CTX Concentration [ Time Frame: 16 week ]
    serum C-terminal telopeptide of type 1 collagen concentration as nmol/L



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Grant/Funding Number: KRF, Korean Government )
First Posted: June 13, 2012    Key Record Dates
Results First Posted: October 2, 2012
Last Update Posted: October 2, 2012
Last Verified: August 2012

Keywords provided by Yongsoon Park, 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