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Marine Oils and Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Whale blubber oil

Cod liver oil

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Whale blubber oil

Cod liver oil

Outcomes

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

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)

To detect a difference between groups in quality of life using SF-36

To see a group difference in functional level using MHAQ

Full Information

NCT ID

NCT00805116

First Posted

December 8, 2008

Last Updated

May 6, 2016

Sponsor

National Institute of Nutrition and Seafood Research, Norway

1. Study Identification

Unique Protocol Identification Number

NCT00805116

Brief Title

Marine Oils and Arthritis

Official Title

Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

Recruitment to slow, most patients to well for treatment

Study Start Date

December 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Institute of Nutrition and Seafood Research, Norway

4. Oversight

Data Monitoring Committee

5. Study Description

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

Detailed Description

Not relevant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Whale blubber oil

Arm Title

Arm Type

Active Comparator

Arm Description

Cod liver oil

Intervention Type

Dietary Supplement

Intervention Name(s)

Whale blubber oil

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Cod liver oil

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

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)

Title

To detect a difference between groups in quality of life using SF-36

Time Frame

Study end (4 months)

Title

To see a group difference in functional level using MHAQ

Time Frame

Study end (4 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Livar Frøyland, Dr

Organizational Affiliation

NIFES

Official's Role

Study Director

12. IPD Sharing Statement

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Marine Oils and Arthritis

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