Marine Oils and Arthritis - Full Text View

Sponsored by:	National Institute of Nutrition and Seafood Research, Norway
Information provided by:	National Institute of Nutrition and Seafood Research, Norway
ClinicalTrials.gov Identifier:	NCT00805116

Purpose

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

Condition	Intervention
Rheumatoid Arthritis	Dietary Supplement: Whale blubber oil Dietary Supplement: Cod liver oil

MedlinePlus related topics: Dietary Supplements Diets Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis

Further study details as provided by National Institute of Nutrition and Seafood Research, Norway:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
To detect a difference between groups in quality of life using SF-36 [ Time Frame: Study end (4 months) ] [ Designated as safety issue: No ]
To see a group difference in functional level using MHAQ [ Time Frame: Study end (4 months) ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Whale blubber oil	Dietary Supplement: Whale blubber oil 15 ml/day for 4 months, divided on dosage morning and evening, orally.
2: Active Comparator Cod liver oil	Dietary Supplement: Cod liver oil 15 ml/day for 4 months, divided on dosage morning and evening, taken orally

Detailed Description:

Not relevant

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805116

Contacts

Contact: Tor Magne Madland, Dr. med

55975420

Locations

Norway
Haukeland University Hospital, Section for Rheumatology	Recruiting
Bergen, Norway

Sponsors and Collaborators

National Institute of Nutrition and Seafood Research, Norway

Investigators

Study Director:

Livar Frøyland, Dr

NIFES

More Information

No publications provided

Responsible Party:	NIFES ( Dr. Livar Frøyland )
Study ID Numbers:	1523 Hvalolje (NIFES), REK VEST 257.07, NSD 17989
Study First Received:	December 8, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00805116 History of Changes
Health Authority:	Norway: Directorate for Health and Social Affairs; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Vitamins
Cod Liver Oil
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Trace Elements
Micronutrients
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Joint Diseases
Cod Liver Oil
Growth Substances
Physiological Effects of Drugs
Arthritis, Rheumatoid

Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Vitamins
Connective Tissue Diseases
Micronutrients

ClinicalTrials.gov processed this record on May 07, 2009