Marine Oils and Arthritis

NCT00805116 | Terminated

• 3 other identifiers: 1523 Hvalolje (NIFES)REK VEST 257.07NSD 17989
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (2)

1

EXPERIMENTAL

Whale blubber oil

Dietary Supplement: Whale blubber oil

2

ACTIVE COMPARATOR

Cod liver oil

Dietary Supplement: Cod liver oil

Interventions

Whale blubber oil DIETARY_SUPPLEMENT

15 ml/day for 4 months, divided on dosage morning and evening, orally.

1

Cod liver oil DIETARY_SUPPLEMENT

15 ml/day for 4 months, divided on dosage morning and evening, taken orally

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Nutrition and Seafood Research, Norway: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Cod Liver Oil

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Fish Oils; Oils

Study Officials

• Livar Frøyland, Dr

  NIFES

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 9, 2016

Record last verified: 2016-05