N-3 PUFA and Rheumatoid Arthritis in Korea

August 30, 2012 updated by: Yongsoon Park, Hanyang University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N-3 PUFA
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
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
Other Names:
  • Ropufa 75 n-3, DSM Nutritional products, Switzerland
Placebo Comparator: Placebo
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Dietary supplement: Placebo
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of NSAID
Time Frame: 16 week
Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
16 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 week
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)
16 week
Patient's Global Assessment
Time Frame: 16 week
Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)
16 week
Pain Scale
Time Frame: 16 week
Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)
16 week
Osteocalcin Concentration
Time Frame: 16 week
serum Osteocalcin concentration as nmol/L
16 week
BSAP Concentration
Time Frame: 16 week
serum bone specific alkaline phosphatase concentration as U/L
16 week
CTX Concentration
Time Frame: 16 week
serum C-terminal telopeptide of type 1 collagen concentration as nmol/L
16 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Investigators

  • Principal Investigator: Yongsoon Park, PhD, Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYUH-C55
  • KRF-2010-000-8656 (Other Grant/Funding Number: KRF, Korean Government)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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