Marine Oils and Arthritis

This study has been terminated.
(Recruitment to slow, most patients to well for treatment)
Sponsor:
Information provided by:
National Institute of Nutrition and Seafood Research, Norway
ClinicalTrials.gov Identifier:
NCT00805116
First received: December 8, 2008
Last updated: January 7, 2010
Last verified: January 2010
  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

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

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: Dr. Livar Frøyland, NIFES
ClinicalTrials.gov Identifier: NCT00805116     History of Changes
Other Study ID Numbers: 1523 Hvalolje (NIFES), REK VEST 257.07, NSD 17989
Study First Received: December 8, 2008
Last Updated: January 7, 2010
Health Authority: Norway: Directorate of Health
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cod Liver Oil
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014