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N-3 PUFA and Rheumatoid Arthritis in Korea

NCT ID: NCT01618019

Last Updated: 2012-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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n-3 PUFA rheumatoid arthritis inflammation eicosanoids bone turnover markers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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N-3 PUFA

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

Group Type EXPERIMENTAL

Omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Omega-3 fatty acid

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ropufa 75 n-3, DSM Nutritional products, Switzerland

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Yongsoon Park

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongsoon Park, PhD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

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Hanyang university hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 23333088 (View on PubMed)

Other Identifiers

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KRF-2010-000-8656

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HYUH-C55

Identifier Type: -

Identifier Source: org_study_id