Marine Oils and Arthritis

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Dietary Supplement: Whale blubber oil; Dietary Supplement: Cod liver oil

• Registration Number: NCT00805116
• Lead Sponsor: National Institute of Nutrition and Seafood Research, Norway

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

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-06
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Whale blubber oil	Whale blubber oil
2	Cod liver oil	Cod liver oil

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)