Rheumatoid Arthritis
Conditions
Brief summary
NSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk. Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. The aim is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with cod liver oil reduce the intensity of joint pain in patients with R.A (primary outcome). Patients are assessed at inclusion and after study (4 months) during routine polyclinical visit. Patients are called for interview after 6 and 12 weeks. Secondary outcomes are e.g. morning stiffness, quality of life and functional level
Detailed description
Not relevant
Interventions
DIETARY_SUPPLEMENTWhale blubber oil
15 ml/day for 4 months, divided on dosage morning and evening, orally.
DIETARY_SUPPLEMENTCod liver oil
15 ml/day for 4 months, divided on dosage morning and evening, taken orally
Sponsors
National Institute of Nutrition and Seafood Research, Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rheumatoid arthritis patients according to American College of Rheumatology criteria (with active disease and in remission). Intensity of joint pain last week (30 mm or more on 100 mm Visual analogue scale). Stable use of DMARDS and no corticosteroid injections last 4 weeks before study and during study.
Exclusion criteria
* Non-Norwegian speaking/reading or not understanding study design or non-compliance. Pregnant/lactating women. Bleeder disease, known HIV or hepatitis, medication with Marevan (blood thinner). Not willing or possible to stop taking regular omega-3 supplements during study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To detect a difference in 10 mm on visual analogue scale (intensity of joint pain last week) between the two treatment groups | At study end (4 months) |
Secondary
| Measure | Time frame |
|---|---|
| To detect a group difference in morning stiffness last week in minutes (720 min = 12 hours are limit for duration of morning stiffness recorded) | Study end (4 months) |
| To detect a difference between groups in quality of life using SF-36 | Study end (4 months) |
| To see a group difference in functional level using MHAQ | Study end (4 months) |
Outcome results
None listed