NCT01618019

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 2, 2012

Completed
Last Updated

October 2, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

June 8, 2012

Results QC Date

June 17, 2012

Last Update Submit

August 30, 2012

Conditions

Rheumatoid Arthritis

Keywords

n-3 PUFArheumatoid arthritisinflammationeicosanoidsbone turnover markers

Outcome Measures

Primary Outcomes (1)

  • Dose of NSAID

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

    16 week

Secondary Outcomes (7)

  • Duration of Morning Stiffness

    16 week

  • Physician's Global Assessment

    16 week

  • Patient's Global Assessment

    16 week

  • Pain Scale

    16 week

  • Osteocalcin Concentration

    16 week

  • +2 more secondary outcomes

Study Arms (2)

N-3 PUFA

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

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

Also known as: Ropufa 75 n-3, DSM Nutritional products, Switzerland
N-3 PUFA
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang university hospital

Seoul, 133-792, South Korea

Location

Related Publications (1)

  • Park Y, Lee A, Shim SC, Lee JH, Choe JY, Ahn H, Choi CB, Sung YK, Bae SC. Effect of n-3 polyunsaturated fatty acid supplementation in patients with rheumatoid arthritis: a 16-week randomized, double-blind, placebo-controlled, parallel-design multicenter study in Korea. J Nutr Biochem. 2013 Jul;24(7):1367-72. doi: 10.1016/j.jnutbio.2012.11.004. Epub 2013 Jan 17.

    PMID: 23333088DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidInflammation

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Results Point of Contact

Title
Dr. Yongsoon Park
Organization
Hanyang University
yongsoon@hanyang.ac.kr
82-2-2220-1205

Study Officials

  • Yongsoon Park, PhD

    Hanyang University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 13, 2012

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 2, 2012

Results First Posted

October 2, 2012

Record last verified: 2012-08

Locations

KR(1)