N-3 PUFA and Rheumatoid Arthritis in Korea

Hanyang University

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Dietary Supplement: Omega-3 fatty acid; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01618019

KRF-2010-000-8656 (Other Grant/Funding Number)

HYUH-C55

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

109 participants in 2 patient groups, including a placebo group

N-3 PUFA

Experimental group

Description:

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

Treatment:

Dietary Supplement: Omega-3 fatty acid

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo