Skip to main content
OpenTrials
Completed

NCT Number: NCT01618019

N-3 PUFA and Rheumatoid Arthritis in Korea

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Inflammation Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanyang university hospital

Seoul, 133-792, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 fatty acid

Dietary Supplement

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

Other names: Ropufa 75 n-3, DSM Nutritional products, Switzerland

Placebo

Dietary Supplement

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

Primary outcomes

  1. Dose of NSAID

    Time frame: 16 week

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

Secondary outcomes

  1. Duration of Morning Stiffness

    Time frame: 16 week

    Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.

  2. Physician's Global Assessment

    Time frame: 16 week

    Physician's global assessment is ranged from 0 to 10 by the assessing physician.

    (0= no pain; 10= very severe pain)

  3. Patient's Global Assessment

    Time frame: 16 week

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

  4. Pain Scale

    Time frame: 16 week

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

  5. Osteocalcin Concentration

    Time frame: 16 week

    serum Osteocalcin concentration as nmol/L

  6. BSAP Concentration

    Time frame: 16 week

    serum bone specific alkaline phosphatase concentration as U/L

  7. CTX Concentration

    Time frame: 16 week

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

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Registry information

Official study title

Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2012
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.