Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

N-3 PUFA and Rheumatoid Arthritis in Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Korea, Republic of
Hanyang university hospital
Seoul, Korea, Republic of, 133-792
Sponsors and Collaborators
Hanyang University
Investigators
Layout table for investigator information
Principal Investigator: Yongsoon Park, PhD Hanyang University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Yongsoon Park, Associate Professor, Hanyang University
ClinicalTrials.gov Identifier: NCT01618019    
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:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases