N-3 PUFA and Rheumatoid Arthritis in Korea

Study Overview
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Brief Summary
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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.

Official Title
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Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Dietary Supplement: Omega-3 fatty acid
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-3 PUFA<br>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<br>* 5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid<br>* Other names: Ropufa 75 n-3, DSM Nutritional products, Switzerland;|
| Placebo Comparator: Placebo<br>5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) | Dietary Supplement: Placebo<br>* 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of NSAID | Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day | 16 week | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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n-3 PUFA, rheumatoid arthritis, inflammation, eicosanoids, bone turnover markers