Rheumatoid Arthritis Clinical Trial
Official title:
Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis
Verified date | August 2012 |
Source | Hanyang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 109 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hanyang university hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanyang University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose of NSAID | Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day | 16 week | Yes |
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. | 16 week | Yes |
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) |
16 week | Yes |
Secondary | Patient's Global Assessment | Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition) | 16 week | Yes |
Secondary | Pain Scale | Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain) | 16 week | Yes |
Secondary | Osteocalcin Concentration | serum Osteocalcin concentration as nmol/L | 16 week | No |
Secondary | BSAP Concentration | serum bone specific alkaline phosphatase concentration as U/L | 16 week | No |
Secondary | CTX Concentration | serum C-terminal telopeptide of type 1 collagen concentration as nmol/L | 16 week | No |
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