N/A
N=109
N-3 PUFA and Rheumatoid Arthritis in Korea
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01618019 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Dose of NSAID — 319.72; 301.58 mg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Omega-3 fatty acid (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hanyang University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose of NSAID |
319.72; 301.58 | — |
| SECONDARY Duration of Morning Stiffness |
40.10; 17.55 | — |
| SECONDARY Physician's Global Assessment |
1.88; 1.60 | — |
| SECONDARY Patient's Global Assessment |
4.00; 4.01 | — |
| SECONDARY Pain Scale |
35.85; 28.75 | — |
| SECONDARY Osteocalcin Concentration |
0.90; 0.87 | — |
| SECONDARY BSAP Concentration |
12.31; 12.27 | — |
| SECONDARY CTX Concentration |
1.41; 1.35 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01618019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.