Trial Outcomes & Findings for N-3 PUFA and Rheumatoid Arthritis in Korea (NCT NCT01618019)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

16 week

Results posted on

2012-10-02

Participant Flow

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.

Patients receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.

Participant milestones

Participant milestones
Measure	N-3 PUFA 5 capsules/day of 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)
Overall Study STARTED	55	54
Overall Study COMPLETED	41	40
Overall Study NOT COMPLETED	14	14

Reasons for withdrawal

Reasons for withdrawal
Measure	N-3 PUFA 5 capsules/day of 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)
Overall Study Withdrawal by Subject	14	14

Baseline Characteristics

N-3 PUFA and Rheumatoid Arthritis in Korea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-3 PUFA n=55 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=54 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)	Total n=109 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	52 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	49.51 years STANDARD_DEVIATION 10.71 • n=5 Participants	48.67 years STANDARD_DEVIATION 8.91 • n=7 Participants	49.09 years STANDARD_DEVIATION 9.83 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	50 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Korea, Republic of	55 participants n=5 Participants	54 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 week

Population: 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.

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

Outcome measures

Outcome measures
Measure	N-3 PUFA n=41 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=40 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Dose of NSAID	319.72 mg Standard Deviation 407.10	301.58 mg Standard Deviation 337.18

SECONDARY outcome

Timeframe: 16 week

Population: 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

Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.

Outcome measures

Outcome measures
Measure	N-3 PUFA n=41 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=40 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Duration of Morning Stiffness	40.10 minutes Standard Deviation 79.28	17.55 minutes Standard Deviation 29.20

SECONDARY outcome

Timeframe: 16 week

Population: Per-protocol analysis (except for drop out patients) Measurement of Physician's global assessment at 16 weeks.

Physician's global assessment is ranged from 0 to 10 by the assessing physician. (0= no pain; 10= very severe pain)

Outcome measures

Outcome measures
Measure	N-3 PUFA n=41 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=40 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Physician's Global Assessment	1.88 units on a scale Standard Deviation 1.83	1.60 units on a scale Standard Deviation 1.75

SECONDARY outcome

Timeframe: 16 week

Population: Per-protocol analysis (except for drop out patients) Measurement of Patient's global assessment at 16 week.

Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)

Outcome measures

Outcome measures
Measure	N-3 PUFA n=41 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=40 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Patient's Global Assessment	4.00 units on a scale Standard Deviation 2.57	4.01 units on a scale Standard Deviation 2.22

SECONDARY outcome

Timeframe: 16 week

Population: Per-protocol analysis (except for drop out patients) Measurement of Pain scale at 16 week.

Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)

Outcome measures

Outcome measures
Measure	N-3 PUFA n=41 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=40 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Pain Scale	35.85 units on a scale Standard Deviation 26.41	28.75 units on a scale Standard Deviation 20.90

SECONDARY outcome

Timeframe: 16 week

Population: Per-protocol anlysis (except for drop out patients) serum Osteocalcain concentration at 16 week

serum Osteocalcin concentration as nmol/L

Outcome measures

Outcome measures
Measure	N-3 PUFA n=41 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=40 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Osteocalcin Concentration	0.90 nmol/L Standard Deviation 0.36	0.87 nmol/L Standard Deviation 0.29

SECONDARY outcome

Timeframe: 16 week

Population: Per-protocol analysis (except for drop out patients) serum bone specific alkaline phosphatase concentration at 16 week

serum bone specific alkaline phosphatase concentration as U/L

Outcome measures

Outcome measures
Measure	N-3 PUFA n=41 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=40 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
BSAP Concentration	12.31 U/L Standard Deviation 4.85	12.27 U/L Standard Deviation 5.45

SECONDARY outcome

Timeframe: 16 week

Population: Per-protocol analysis (except for drop out patients) serum C-terminal telopeptide of type 1 collagen concentration at 16 week

serum C-terminal telopeptide of type 1 collagen concentration as nmol/L

Outcome measures

Outcome measures
Measure	N-3 PUFA n=41 Participants 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid	Placebo n=40 Participants 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
CTX Concentration	1.41 nmol/L Standard Error 1.05	1.35 nmol/L Standard Error 1.00

Adverse Events

N-3 PUFA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yongsoon Park

Hanyang University

Phone: 82-2-2220-1205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place