Rheumatoid Arthritis
Conditions
Keywords
n-3 PUFA, rheumatoid arthritis, inflammation, eicosanoids, bone turnover markers
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 fatty acid
5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
DIETARY_SUPPLEMENTPlacebo
5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Sponsors
Hanyang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of NSAID | 16 week | Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Assessment | 16 week | Physician's global assessment is ranged from 0 to 10 by the assessing physician. (0= no pain; 10= very severe pain) |
| Patient's Global Assessment | 16 week | Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition) |
| Pain Scale | 16 week | Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain) |
| Duration of Morning Stiffness | 16 week | Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning. |
| BSAP Concentration | 16 week | serum bone specific alkaline phosphatase concentration as U/L |
| CTX Concentration | 16 week | serum C-terminal telopeptide of type 1 collagen concentration as nmol/L |
| Osteocalcin Concentration | 16 week | serum Osteocalcin concentration as nmol/L |
Countries
South Korea
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| N-3 PUFA 5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid | 55 |
| Placebo 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland) | 54 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 14 | 14 |
Baseline characteristics
| Characteristic | Placebo | N-3 PUFA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 51 Participants | 103 Participants |
| Age Continuous | 48.67 years STANDARD_DEVIATION 8.91 | 49.51 years STANDARD_DEVIATION 10.71 | 49.09 years STANDARD_DEVIATION 9.83 |
| Region of Enrollment Korea, Republic of | 54 participants | 55 participants | 109 participants |
| Sex: Female, Male Female | 50 Participants | 51 Participants | 101 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
Primary
Dose of NSAID
Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-3 PUFA | Dose of NSAID | 319.72 mg | Standard Deviation 407.1 |
| Placebo | Dose of NSAID | 301.58 mg | Standard Deviation 337.18 |
Secondary
BSAP Concentration
serum bone specific alkaline phosphatase concentration as U/L
Time frame: 16 week
Population: Per-protocol analysis (except for drop out patients) serum bone specific alkaline phosphatase concentration at 16 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-3 PUFA | BSAP Concentration | 12.31 U/L | Standard Deviation 4.85 |
| Placebo | BSAP Concentration | 12.27 U/L | Standard Deviation 5.45 |
Secondary
CTX Concentration
serum C-terminal telopeptide of type 1 collagen concentration as nmol/L
Time frame: 16 week
Population: Per-protocol analysis (except for drop out patients) serum C-terminal telopeptide of type 1 collagen concentration at 16 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-3 PUFA | CTX Concentration | 1.41 nmol/L | Standard Error 1.05 |
| Placebo | CTX Concentration | 1.35 nmol/L | Standard Error 1 |
Secondary
Duration of Morning Stiffness
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-3 PUFA | Duration of Morning Stiffness | 40.10 minutes | Standard Deviation 79.28 |
| Placebo | Duration of Morning Stiffness | 17.55 minutes | Standard Deviation 29.2 |
Secondary
Osteocalcin Concentration
serum Osteocalcin concentration as nmol/L
Time frame: 16 week
Population: Per-protocol anlysis (except for drop out patients) serum Osteocalcain concentration at 16 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-3 PUFA | Osteocalcin Concentration | 0.90 nmol/L | Standard Deviation 0.36 |
| Placebo | Osteocalcin Concentration | 0.87 nmol/L | Standard Deviation 0.29 |
Secondary
Pain Scale
Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)
Time frame: 16 week
Population: Per-protocol analysis (except for drop out patients) Measurement of Pain scale at 16 week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-3 PUFA | Pain Scale | 35.85 units on a scale | Standard Deviation 26.41 |
| Placebo | Pain Scale | 28.75 units on a scale | Standard Deviation 20.9 |
Secondary
Patient's Global Assessment
Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)
Time frame: 16 week
Population: Per-protocol analysis (except for drop out patients) Measurement of Patient's global assessment at 16 week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-3 PUFA | Patient's Global Assessment | 4.00 units on a scale | Standard Deviation 2.57 |
| Placebo | Patient's Global Assessment | 4.01 units on a scale | Standard Deviation 2.22 |
Secondary
Physician's Global Assessment
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
Population: Per-protocol analysis (except for drop out patients) Measurement of Physician's global assessment at 16 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-3 PUFA | Physician's Global Assessment | 1.88 units on a scale | Standard Deviation 1.83 |
| Placebo | Physician's Global Assessment | 1.60 units on a scale | Standard Deviation 1.75 |