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| ID | Type | Description | Link |
|---|---|---|---|
| KRF-2010-000-8656 | Other Grant/Funding Number | KRF, Korean Government |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-3 PUFA | Experimental | 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid |
|
| Placebo | Placebo Comparator | 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid | Dietary Supplement | 5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose of NSAID | Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day | 16 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 week |
| Physician's Global Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongsoon Park, PhD | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang university hospital | Seoul | 133-792 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23333088 | Derived | 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. |
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Patients receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.
Patients with rheumatoid arthritis diagnosed based on American College of Rheumatology guideline were recruited from Hanyang university hospital in Seoul, Eulji university hospital in Daejun, Catholic university hospital in Daegu, and Maryknoll medical center in Busan between Dec 2010 and Dec 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | N-3 PUFA | 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid |
| FG001 | Placebo | 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N-3 PUFA | 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid |
| BG001 | Placebo | 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose of NSAID | Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day | Per-protocol analysis (except for drop out patients) Measurement of NSAID requirements at 16 weeks, except for 10 in N-3 PUFA and 6 in placebo. | Posted | Mean | Standard Deviation | mg | 16 week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N-3 PUFA | 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yongsoon Park | Hanyang University | 82-2-2220-1205 | yongsoon@hanyang.ac.kr |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Dietary Supplement | 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) |
|
Physician's global assessment is ranged from 0 to 10 by the assessing physician.
(0= no pain; 10= very severe pain)
| 16 week |
| Patient's Global Assessment | Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition) | 16 week |
| Pain Scale | Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain) | 16 week |
| Osteocalcin Concentration | serum Osteocalcin concentration as nmol/L | 16 week |
| BSAP Concentration | serum bone specific alkaline phosphatase concentration as U/L | 16 week |
| CTX Concentration | serum C-terminal telopeptide of type 1 collagen concentration as nmol/L | 16 week |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Per-protocol analysis (except for drop out patients) Measurement of Morning stiffness assessment at 16 weeks, except for 16 in N-3 PUFA and 16 in placebo | Posted | Mean | Standard Deviation | minutes | 16 week |
|
|
|
| Secondary | 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) | Per-protocol analysis (except for drop out patients) Measurement of Physician's global assessment at 16 weeks. | Posted | Mean | Standard Deviation | units on a scale | 16 week |
|
|
|
| Secondary | Patient's Global Assessment | Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition) | Per-protocol analysis (except for drop out patients) Measurement of Patient's global assessment at 16 week. | Posted | Mean | Standard Deviation | units on a scale | 16 week |
|
|
|
| Secondary | Pain Scale | Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain) | Per-protocol analysis (except for drop out patients) Measurement of Pain scale at 16 week. | Posted | Mean | Standard Deviation | units on a scale | 16 week |
|
|
|
| Secondary | Osteocalcin Concentration | serum Osteocalcin concentration as nmol/L | Per-protocol anlysis (except for drop out patients) serum Osteocalcain concentration at 16 week | Posted | Mean | Standard Deviation | nmol/L | 16 week |
|
|
|
| Secondary | BSAP Concentration | serum bone specific alkaline phosphatase concentration as U/L | Per-protocol analysis (except for drop out patients) serum bone specific alkaline phosphatase concentration at 16 week | Posted | Mean | Standard Deviation | U/L | 16 week |
|
|
|
| Secondary | CTX Concentration | serum C-terminal telopeptide of type 1 collagen concentration as nmol/L | Per-protocol analysis (except for drop out patients) serum C-terminal telopeptide of type 1 collagen concentration at 16 week | Posted | Mean | Standard Error | nmol/L | 16 week |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Placebo | 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) | 0 | 54 | 0 | 54 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |