Marine Oils and Arthritis

May 6, 2016 updated by: Marian Kjellevold, National Institute of Nutrition and Seafood Research, Norway

Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Not relevant

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: At study end (4 months)
At study end (4 months)

Secondary Outcome Measures

Outcome 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)
Time Frame: Study end (4 months)
Study end (4 months)
To detect a difference between groups in quality of life using SF-36
Time Frame: Study end (4 months)
Study end (4 months)
To see a group difference in functional level using MHAQ
Time Frame: Study end (4 months)
Study end (4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Nutrition and Seafood Research, Norway

Investigators

  • Study Director: Livar Frøyland, Dr, NIFES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1523 Hvalolje (NIFES)
  • REK VEST 257.07
  • NSD 17989

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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