NCT01618019CompletedNot Applicable
Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hanyang University
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Dose of NSAID
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Placebo Comparator
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Intervention: Placebo (Dietary Supplement)
N-3 PUFA
Experimental
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
Intervention: Omega-3 fatty acid (Dietary Supplement)
Outcomes
Primary Outcomes
Dose of NSAID
Time Frame: 16 week
Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
Secondary Outcomes
- Duration of Morning Stiffness(16 week)
- Physician's Global Assessment(16 week)
- Patient's Global Assessment(16 week)
- Pain Scale(16 week)
- Osteocalcin Concentration(16 week)
- BSAP Concentration(16 week)
- CTX Concentration(16 week)
Investigators
Yongsoon Park
Associate Professor
Hanyang University
Study Sites (1)
Loading locations...
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