N-3 PUFA and Rheumatoid Arthritis in Korea

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618019
• Other study ID #: HYUH-C55
• Secondary ID: KRF-2010-000-865
• Status: Completed
• Phase: N/A
• First received: June 8, 2012
• Last updated: August 30, 2012
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Omega-3 fatty acid
5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
• Placebo
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)

Locations

Country	Name	City	State
Korea, Republic of	Hanyang university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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