Marine Oils and Arthritis

Study Overview
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Brief Summary
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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
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Not relevant

Official Title
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Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Dietary Supplement: Whale blubber oil
* Dietary Supplement: Cod liver oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Whale blubber oil | Dietary Supplement: Whale blubber oil<br>* 15 ml/day for 4 months, divided on dosage morning and evening, orally.<br>|
| Active Comparator: 2<br>Cod liver oil | Dietary Supplement: Cod liver oil<br>* 15 ml/day for 4 months, divided on dosage morning and evening, taken orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |