Marine Oils and Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805116
• Other study ID #: 1523 Hvalolje (NIFES)
• Secondary ID: REK VEST 257.07N
• Status: Terminated
• Phase: N/A
• First received: December 8, 2008
• Last updated: May 6, 2016
• Start date: December 2008
• Est. completion date: October 2009

Study information

• Verified date: May 2016
• Source: National Institute of Nutrition and Seafood Research, Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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

Description:

Not relevant

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Whale blubber oil
15 ml/day for 4 months, divided on dosage morning and evening, orally.
• Cod liver oil
15 ml/day for 4 months, divided on dosage morning and evening, taken orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nutrition and Seafood Research, Norway

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	To detect a difference between groups in quality of life using SF-36		Study end (4 months)	No
Secondary	To see a group difference in functional level using MHAQ		Study end (4 months)	No