Back to resultsN-3 PUFA and Rheumatoid Arthritis in Korea
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Omega-3 fatty acid
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring n-3 PUFA, rheumatoid arthritis, inflammation, eicosanoids, bone turnover markers
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.
Sites / Locations
- Hanyang university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N-3 PUFA
Placebo
Arm Description
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Outcomes
Primary Outcome Measures
Dose of NSAID
Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
Secondary Outcome Measures
Duration of Morning Stiffness
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
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
Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)
Pain Scale
Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)
Osteocalcin Concentration
serum Osteocalcin concentration as nmol/L
BSAP Concentration
serum bone specific alkaline phosphatase concentration as U/L
CTX Concentration
serum C-terminal telopeptide of type 1 collagen concentration as nmol/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01618019
Brief Title
N-3 PUFA and Rheumatoid Arthritis in Korea
Official Title
Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
n-3 PUFA, rheumatoid arthritis, inflammation, eicosanoids, bone turnover markers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-3 PUFA
Arm Type
Experimental
Arm Description
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acid
Other Intervention Name(s)
Ropufa 75 n-3, DSM Nutritional products, Switzerland
Intervention Description
5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Primary Outcome Measure Information:
Title
Dose of NSAID
Description
Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
Time Frame
16 week
Secondary Outcome Measure Information:
Title
Duration of Morning Stiffness
Description
Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.
Time Frame
16 week
Title
Physician's Global Assessment
Description
Physician's global assessment is ranged from 0 to 10 by the assessing physician.
(0= no pain; 10= very severe pain)
Time Frame
16 week
Title
Patient's Global Assessment
Description
Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)
Time Frame
16 week
Title
Pain Scale
Description
Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)
Time Frame
16 week
Title
Osteocalcin Concentration
Description
serum Osteocalcin concentration as nmol/L
Time Frame
16 week
Title
BSAP Concentration
Description
serum bone specific alkaline phosphatase concentration as U/L
Time Frame
16 week
Title
CTX Concentration
Description
serum C-terminal telopeptide of type 1 collagen concentration as nmol/L
Time Frame
16 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongsoon Park, PhD
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang university hospital
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23333088
Citation
Park Y, Lee A, Shim SC, Lee JH, Choe JY, Ahn H, Choi CB, Sung YK, Bae SC. Effect of n-3 polyunsaturated fatty acid supplementation in patients with rheumatoid arthritis: a 16-week randomized, double-blind, placebo-controlled, parallel-design multicenter study in Korea. J Nutr Biochem. 2013 Jul;24(7):1367-72. doi: 10.1016/j.jnutbio.2012.11.004. Epub 2013 Jan 17.
Results Reference
derived
Learn more about this trial
N-3 PUFA and Rheumatoid Arthritis in Korea
We'll reach out to this number within 24 hrs