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Trial record 30 of 99 for:    Oleic Acids

N-3 PUFA and Rheumatoid Arthritis in Korea

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ClinicalTrials.gov Identifier: NCT01618019
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : October 2, 2012
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Yongsoon Park, Hanyang University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition Rheumatoid Arthritis
Interventions Dietary Supplement: Omega-3 fatty acid
Dietary Supplement: Placebo
Enrollment 109
Recruitment Details Patients with rheumatoid arthritis diagnosed based on American College of Rheumatology guideline were recruited from Hanyang university hospital in Seoul, Eulji university hospital in Daejun, Catholic university hospital in Daegu, and Maryknoll medical center in Busan between Dec 2010 and Dec 2011.
Pre-assignment Details Patients receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Period Title: Overall Study
Started 55 54
Completed 41 40
Not Completed 14 14
Reason Not Completed
Withdrawal by Subject             14             14
Arm/Group Title N-3 PUFA Placebo Total
Hide Arm/Group Description 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) Total of all reporting groups
Overall Number of Baseline Participants 55 54 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 109 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  92.7%
52
  96.3%
103
  94.5%
>=65 years
4
   7.3%
2
   3.7%
6
   5.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 54 participants 109 participants
49.51  (10.71) 48.67  (8.91) 49.09  (9.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 109 participants
Female
51
  92.7%
50
  92.6%
101
  92.7%
Male
4
   7.3%
4
   7.4%
8
   7.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 55 participants 54 participants 109 participants
55 54 109
1.Primary Outcome
Title Dose of NSAID
Hide Description Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis (except for drop out patients) Measurement of NSAID requirements at 16 weeks, except for 10 in N-3 PUFA and 6 in placebo.
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description:
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: mg
319.72  (407.10) 301.58  (337.18)
2.Secondary Outcome
Title Duration of Morning Stiffness
Hide Description Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.
Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis (except for drop out patients) Measurement of Morning stiffness assessment at 16 weeks, except for 16 in N-3 PUFA and 16 in placebo
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description:
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: minutes
40.10  (79.28) 17.55  (29.20)
3.Secondary Outcome
Title Physician’s Global Assessment
Hide Description

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

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

Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis (except for drop out patients) Measurement of Physician’s global assessment at 16 weeks.
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description:
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.88  (1.83) 1.60  (1.75)
4.Secondary Outcome
Title Patient’s Global Assessment
Hide Description Patient’s global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)
Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis (except for drop out patients) Measurement of Patient’s global assessment at 16 week.
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description:
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.00  (2.57) 4.01  (2.22)
5.Secondary Outcome
Title Pain Scale
Hide Description Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)
Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis (except for drop out patients) Measurement of Pain scale at 16 week.
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description:
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.85  (26.41) 28.75  (20.90)
6.Secondary Outcome
Title Osteocalcin Concentration
Hide Description serum Osteocalcin concentration as nmol/L
Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol anlysis (except for drop out patients) serum Osteocalcain concentration at 16 week
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description:
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: nmol/L
0.90  (0.36) 0.87  (0.29)
7.Secondary Outcome
Title BSAP Concentration
Hide Description serum bone specific alkaline phosphatase concentration as U/L
Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis (except for drop out patients) serum bone specific alkaline phosphatase concentration at 16 week
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description:
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: U/L
12.31  (4.85) 12.27  (5.45)
8.Secondary Outcome
Title CTX Concentration
Hide Description serum C-terminal telopeptide of type 1 collagen concentration as nmol/L
Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis (except for drop out patients) serum C-terminal telopeptide of type 1 collagen concentration at 16 week
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description:
5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Overall Number of Participants Analyzed 41 40
Mean (Standard Error)
Unit of Measure: nmol/L
1.41  (1.05) 1.35  (1.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-3 PUFA Placebo
Hide Arm/Group Description 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
All-Cause Mortality
N-3 PUFA Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
N-3 PUFA Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-3 PUFA Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/54 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Yongsoon Park
Organization: Hanyang University
Phone: 82-2-2220-1205
Responsible Party: Yongsoon Park, Hanyang University
ClinicalTrials.gov Identifier: NCT01618019     History of Changes
Other Study ID Numbers: HYUH-C55
KRF-2010-000-8656 ( Other Grant/Funding Number: KRF, Korean Government )
First Submitted: June 8, 2012
First Posted: June 13, 2012
Results First Submitted: June 17, 2012
Results First Posted: October 2, 2012
Last Update Posted: October 2, 2012