N-3 PUFA and Rheumatoid Arthritis in Korea

Hanyang University109 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

109

Conditions

Rheumatoid Arthritis

Interventions

Omega-3 fatty acidDIETARY_SUPPLEMENT

5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid

PlaceboDIETARY_SUPPLEMENT

5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hanyang university hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Dose of NSAID

Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day

Time frame: 16 week

Secondary Outcomes

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.

Time frame: 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)

Time frame: 16 week

Patient's Global Assessment

Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)

Time frame: 16 week

Pain Scale

Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)

Time frame: 16 week

Osteocalcin Concentration

serum Osteocalcin concentration as nmol/L

Time frame: 16 week

BSAP Concentration

serum bone specific alkaline phosphatase concentration as U/L

Time frame: 16 week

CTX Concentration

serum C-terminal telopeptide of type 1 collagen concentration as nmol/L

Time frame: 16 week

Data from ClinicalTrials.gov

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